Product Code: LJS FDA class 2 21 CFR 880.5970

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

General Hospital

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days is a catheter designed for placement within the vascular system for extended therapeutic use exceeding 30 days, such as for prolonged intravenous medication administration, chemotherapy, or parenteral nutrition. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LJS, regulated under 21 CFR 880.5970, within the General Hospital medical specialty. This device is an implant.

View on FDA

510(k)s

298

FEI Numbers

Registration Numbers

Unique Applicants

122

Years Active

Basic Information

Product Code: LJS
Device Class: FDA class 2
Regulation Number: 880.5970
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 298 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251212	Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)	Jul 01, 2025	Substantially Equivalent	Access Vascular, Inc.
K243484	PM2+ System and SmartPICC Stylet	May 29, 2025	Substantially Equivalent	Piccolo Medical, Inc.
K241587	pilot TLS	Feb 26, 2025	Substantially Equivalent	Vygon Corporation
K241910	Neonav ECG Tip Location System	Jan 19, 2025	Substantially Equivalent	Navi Medical Technologies
K243941	HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)	Jan 17, 2025	Substantially Equivalent	Access Vascular, Inc.
K240486	PM2 System and ECGuide Connector	Sep 08, 2024	Substantially Equivalent	Piccolo Medical, Inc.
K233149	CATHTONG III Tapered PICC Catheter	Dec 01, 2023	Substantially Equivalent	L&Z US, Inc.
K230669	L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters	Nov 30, 2023	Substantially Equivalent	Argon Medical Devices
K232594	CATHTONG II PICC Catheter	Sep 22, 2023	Substantially Equivalent	L&Z US, Inc.
K232571	CATHTONG II PICC Catheter	Sep 22, 2023	Substantially Equivalent	L&Z US, Inc.
K222232	Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly	Aug 24, 2022	Substantially Equivalent	Bard Access Systems, Inc.
K220363	VPS Rhythm DLX Device with TipTracker Technology	Aug 22, 2022	Substantially Equivalent	Arrow International, LLC (a subsidiary of Teleflex, Inc.)
K213550	HydroPICC 5F Dual Lumen Catheter	May 04, 2022	Substantially Equivalent	Access Vascular Inc
K210264	BD PowerPiCC Catheter	Jul 30, 2021	Substantially Equivalent	Bard Access Systems, Inc.
K201452	Groshong NXT PICC Catheter	Mar 12, 2021	Substantially Equivalent	C.R. Bard, Inc.
K200037	Piccolo Medical SmartPICC System	Jan 22, 2021	Substantially Equivalent	Piccolo Medical, Inc
K192246	Biowy PICC Catheter S Kit	Apr 30, 2020	Substantially Equivalent	Biowy Corporation
K193015	HydroPICC (PICC-142)	Feb 20, 2020	Substantially Equivalent	Access Vascular, Inc
K180546	Jet Power Injectable PICC	Nov 21, 2018	Substantially Equivalent	Jet Medical, Inc.
K181904	5 FR Dual Lumen Piper PICC	Sep 25, 2018	Substantially Equivalent	Piper Access LLC
K180560	Sherlock 3CG+ T ip Confirmation System	Jun 18, 2018	Substantially Equivalent	C.R. Bard, Inc.
K173956	Biowy PlCC Catheter	May 21, 2018	Substantially Equivalent	Biowy Corporation
K180548	3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology	Apr 26, 2018	Substantially Equivalent	C.R. Bard, Inc (Bard has joined BD)
K172511	Hickman TriFusion Catheter	Apr 20, 2018	Substantially Equivalent	C.R. Bard, Inc
K180567	C3 Wave System	Apr 12, 2018	Substantially Equivalent	Medical Components, Inc. (dba Medcomp)
K172899	Vygon PICCs	Feb 26, 2018	Substantially Equivalent	Vygon USA
K171994	Silicone Peripherally Inserted Central Venous Catheter Set/Tray	Feb 22, 2018	Substantially Equivalent	Cook Incorporated
K172885	HydroPICC	Feb 20, 2018	Substantially Equivalent	Access Vascular, Inc
K170934	C3 Wave System	Dec 06, 2017	Substantially Equivalent	Medical Components, Inc (Dba Medcomp_
K171931	Celerity ECG Cable Accessory Pack	Oct 26, 2017	Substantially Equivalent	Medcomp (Medical Components, Inc.)
K172397	Sherlock 3CG Tip Positioning System Stylet	Sep 29, 2017	Substantially Equivalent	C.R. Bard, Inc.
K172039	CATHTONG II PICC Catheter	Aug 03, 2017	Substantially Equivalent	L&Z US, Inc.
K170486	CATHTONG II PICC Catheter	May 25, 2017	Substantially Equivalent	L&Z US, Inc.
K162441	PowerPICC Provena Catheters with SOLO Valve Technology	Apr 24, 2017	Substantially Equivalent	C.R. BARD, INC
K163452	PICC Maximal Barrier Nursing Kit	Feb 03, 2017	Unknown	Navilyst Medical, Inc.
K160925	VPS Rhythm Device with TipTracker Technology	Dec 22, 2016	Substantially Equivalent	ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.)
K162443	PowerPICC Provena Catheters	Oct 25, 2016	Substantially Equivalent	C.R. BARD, INC.
K161496	Turbo-Flo PICC Sets	Oct 07, 2016	Substantially Equivalent	COOK INCORPORATED
K161765	CG+ Arrow JACC	Sep 06, 2016	Substantially Equivalent	ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX,
K153469	Cathtong I PICC Catheter	Sep 01, 2016	Substantially Equivalent	L&Z US, INC.
K151985	PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter	Jun 14, 2016	Substantially Equivalent	C.R. Bard, Inc
K152819	Amecath Peripheral inserted Central Venous Catheter Sets	Feb 05, 2016	Substantially Equivalent	AMECO MEDICAL INDUSTRIES
K153487	CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS	Feb 04, 2016	Substantially Equivalent	ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.)
K153423	CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC	Jan 28, 2016	Substantially Equivalent	ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
K152261	PICC Tip Positioning Aid	Oct 21, 2015	Substantially Equivalent	NOSTIX LLC
K152409	Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC	Sep 24, 2015	Substantially Equivalent	NAVILYST MEDICAL, INC.
K143238	C3 Wave	Apr 24, 2015	Substantially Equivalent	MEDCOMP (MEDICAL COMPONENTS)
K150527	Xcela Power Injectable PICC	Mar 31, 2015	Substantially Equivalent	NAVILYST MEDICAL, INC.
K150448	NMI PICC III and NMI PICC IV	Mar 19, 2015	Substantially Equivalent	NAVILYST MEDICAL, INC.
K142889	Celerity PICC Tip Confirmation System	Jan 27, 2015	Substantially Equivalent	ANGIODYNAMICS, INC.
K141634	NAUTILUS DELTA	Jan 27, 2015	Substantially Equivalent	ROMEDEX INTERNATIONAL SRL
K142267	Sherlock 3CG Tip Positioning System Stylet	Oct 17, 2014	Substantially Equivalent	C.R.Bard, Inc.
K142616	PICC Maximal Barrier Nursing Kit	Oct 14, 2014	Substantially Equivalent	NAVILYST MEDICAL, INC.
K141633	PRO-PICC WITH VALVE TECHNOLOGY	Sep 29, 2014	Substantially Equivalent	MEDICAL COMPONENTS INC
K141818	TURBO-JECT PICC SETS	Aug 05, 2014	Substantially Equivalent	COOK CORPORATED
K141151	CT MIDLINE	Jul 08, 2014	Substantially Equivalent	MEDCOMP (MEDICAL COMPONENTS, INC.)
K140799	CELERITY SYSYEM	Jun 13, 2014	Substantially Equivalent	MEDCOMP (MEDICAL COMPONENTS, INC.)
K140345	THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)	Mar 14, 2014	Substantially Equivalent	C.R. BARD, INC.
K140266	NMI PICC IV	Mar 05, 2014	Substantially Equivalent	NAVILYST MEDICAL, INC.
K133634	SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET	Dec 23, 2013	Substantially Equivalent	COOK, INC.
K133264	NMI PICC III	Nov 20, 2013	Substantially Equivalent	NAVILYST MEDICAL, INC.
K132567	ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN	Nov 05, 2013	Substantially Equivalent	COVIDIEN
K130897	MEDCOMP VASCU-PICC WITH VALVE	Oct 22, 2013	Substantially Equivalent	MEDCOMP (MEDICAL COMPONENTS)
K132885	TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET	Oct 11, 2013	Substantially Equivalent	COOK INCORPORATED
K132334	TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET	Aug 16, 2013	Substantially Equivalent	COOK, INC.
K131687	6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET	Aug 16, 2013	Substantially Equivalent	MEDICAL COMPONENTS INC
K131942	NMI PICC III CATHETER, NMI HPICC III CATHETER	Jul 31, 2013	Substantially Equivalent	NAVILYST MEDICAL, INC.
K130507	FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER	Jun 03, 2013	Substantially Equivalent	FOOTPRINT MEDICAL INC.
K123617	3F PRO-PICC	May 15, 2013	Substantially Equivalent	MEDICAL COMPONENTS INC
K131038	NMI PICC MAXIMAL BARRIER NURSING KITS	May 09, 2013	Substantially Equivalent	NAVILYST MEDICAL, INC.
K130876	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	Apr 26, 2013	Substantially Equivalent	ARROW INTERNATIONAL, INC.
K130034	UNI-PICC	Mar 08, 2013	Substantially Equivalent	HEALTH LINE INTERNATIONAL CORPORATION
K123759	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	Jan 03, 2013	Substantially Equivalent	ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX,
K122423	VASU-PICC	Dec 12, 2012	Substantially Equivalent	MEDICAL COMPONENTS INC
K121501	ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)	Nov 29, 2012	Substantially Equivalent	ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
K113225	NYLUS PICC	Nov 06, 2012	Substantially Equivalent	SEMPRUS BIOSCIENCES
K122882	NMI HPICC III	Oct 18, 2012	Substantially Equivalent	NAVILYST MEDICAL, INC.
K122545	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	Sep 20, 2012	Substantially Equivalent	ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
K121941	ARROW PICC POWERED BY ARROW VPS STYLET	Sep 07, 2012	Substantially Equivalent	ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
K121089	NMI PICC III	Aug 23, 2012	Substantially Equivalent	NAVILYST MEDICAL, INC.
K121990	PICC CONVENIENCE KIT	Aug 03, 2012	Substantially Equivalent	NAVILYST MEDICAL, INC.
K113277	ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS	Jun 21, 2012	Substantially Equivalent	ARROW INTERNATIONAL, INC.
K121094	MEDCOMP VASCU-PICC & MIDLINE CATHETERS	Jun 06, 2012	Substantially Equivalent	MEDICAL COMPONENTS INC
K112896	ARRW EVOLUTION	May 10, 2012	Substantially Equivalent	ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
K120981	2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC	May 02, 2012	Substantially Equivalent	MEDICAL COMPONENTS INC
K120980	1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC	May 02, 2012	Substantially Equivalent	MEDICAL COMPONENTS INC
K113808	THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)	Mar 19, 2012	Substantially Equivalent	C.R. BARD, INC.
K113043	DIRECT ANTIBIOTIC INFUSION KIT	Dec 20, 2011	Substantially Equivalent	SUMMIT MEDICAL PRODUCTS, INC
K112744	SAPIENS TIP CONFIRMATION SYSTEM	Oct 20, 2011	Substantially Equivalent	C.R. BARD, INC.
K110914	TRIPLE LUMEN PFM PICC	Sep 21, 2011	Substantially Equivalent	PFM MEDICAL, INC
K110627	NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER	Aug 12, 2011	Substantially Equivalent	MARVAO MEDICAL DEVICES, LTD.
K111906	XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY	Jul 29, 2011	Substantially Equivalent	NAVILYST MEDICAL, INC.
K111244	TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)	Jun 14, 2011	Substantially Equivalent	COOK, INC.
K102966	2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC	Dec 21, 2010	Substantially Equivalent	MEDCOMP
K102159	POWERPICC SV CATHETERS	Nov 17, 2010	Substantially Equivalent	C.R. BARD, INC.
K101326	NMI IC	Sep 02, 2010	Substantially Equivalent	NAVILYST MEDICAL, INC.
K100635	ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504	Aug 27, 2010	Substantially Equivalent	ARROW INTL., INC.
K101329	SYNERGY CT PICC	Aug 19, 2010	Substantially Equivalent	HEALTH LINE INTERNATIONAL CORPORATION
K093775	EVGUIDE TIP LOCATION SYSTEM	Jul 15, 2010	Substantially Equivalent	ROMEDEX INTERNATIONAL SRL
K092306	SECURACATH UNIVERSAL	Jul 09, 2010	Substantially Equivalent	INTERRAD MEDICAL, INC.
K093406	MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519	Mar 25, 2010	Substantially Equivalent	ANGIODYNAMICS, INC.
K093927	6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER	Feb 04, 2010	Substantially Equivalent	C.R. BARD, INC.
K093252	FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER	Dec 17, 2009	Substantially Equivalent	FOOTPRINT MEDICAL INC.
K093366	NMI PICC II	Nov 24, 2009	Substantially Equivalent	NAVILYST MEDICAL, INC.
K093309	PRO-LINE CT (BASIC TRAY) MODEL MR28036101	Nov 24, 2009	Substantially Equivalent	MEDCOMP (MEDICAL COMPONENTS)
K092040	PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240	Nov 18, 2009	Substantially Equivalent	R4 VASCULAR, INC.
K091924	VPS CATHETER	Nov 18, 2009	Substantially Equivalent	VASONOVA INC.
K092347	PRO-PICC CT	Sep 16, 2009	Substantially Equivalent	MEDCOMP
K091953	PRO-PICC	Sep 16, 2009	Substantially Equivalent	MEDCOMP
K091488	FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C	Sep 14, 2009	Substantially Equivalent	FOOTPRINT MEDICAL
K091324	SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET	Aug 07, 2009	Substantially Equivalent	C.R. BARD, INC.
K091586	VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN	Jul 23, 2009	Substantially Equivalent	MEDCOMP
K091670	BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER	Jul 01, 2009	Substantially Equivalent	BECTON DICKINSON & CO.
K091466	1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50	Jun 17, 2009	Substantially Equivalent	MEDCOMP
K091261	NMI PICC	May 12, 2009	Substantially Equivalent	NAVILYST MEDICAL, INC.
K083920	FLOWPICC CATHETER	May 01, 2009	Substantially Equivalent	VASONOVA INC.
K083873	PICC (CT RATED AND NON-RATED)	Mar 19, 2009	Substantially Equivalent	PFM MEDICAL, INC
K083763	ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN	Mar 16, 2009	Substantially Equivalent	R4 VASCULAR, INC.
K082481	FLOWPICC CATHETER	Dec 17, 2008	Substantially Equivalent	VASONOVA INC.
K081904	PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)	Sep 23, 2008	Substantially Equivalent	MEDCOMP
K080604	PRESSURE INJFECTABLE PICC	Jun 27, 2008	Substantially Equivalent	ARROW INTERNATIONAL, INC.
K073451	PRESSURE INJECTABLE PICC	Jan 15, 2008	Substantially Equivalent	ARROW INTERNATIONAL, INC.
K072518	CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)	Dec 20, 2007	Substantially Equivalent	CRS MEDICAL DIAGNOSTICS INC.
K072625	TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)	Dec 13, 2007	Substantially Equivalent	COOK, INC.
K072509	PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY	Nov 26, 2007	Substantially Equivalent	MEDCOMP
K072391	PFM PICC	Nov 19, 2007	Substantially Equivalent	PFM MEDICAL, INC
K071875	V-CATH POLY PICC	Nov 05, 2007	Substantially Equivalent	HDC CORP.
K072230	POWERPICC SOLO	Oct 05, 2007	Substantially Equivalent	C.R. BARD, INC.
K072196	ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT	Aug 27, 2007	Substantially Equivalent	ANGIODYNAMICS, INC.
K071361	R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005	Aug 20, 2007	Substantially Equivalent	R4 VASCULAR, INC.
K070002	BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER	Aug 17, 2007	Substantially Equivalent	BOSTONSCIENTIFIC
K070613	ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT	Jun 29, 2007	Substantially Equivalent	ANGIODYNAMICS, INC.
K070996	4 FR SINGLE LUMEN (SL) POWERPICC CATHETER	May 08, 2007	Substantially Equivalent	C.R. BARD, INC.
K063363	FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE	May 07, 2007	Substantially Equivalent	FLEXICATH LTD.
K070615	ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT	May 04, 2007	Substantially Equivalent	ANGIODYNAMICS, INC.
K063848	POWERGROSHONG PICC CATHETER	Apr 04, 2007	Substantially Equivalent	C.R. BARD, INC.
K062579	OMNIPICC P.I.	Nov 28, 2006	Substantially Equivalent	RITA MEDICAL SYSTEMS, INC.
K063240	SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR	Nov 21, 2006	Substantially Equivalent	C.R. BARD, INC.
K062425	LIFECATH S PICC AND MIDLINE CATHETER	Sep 15, 2006	Substantially Equivalent	VYGON CORP.
K052475	VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS	Sep 14, 2006	Substantially Equivalent	VYGON US LLC
K061289	ARROW PRESSURE INJECTABLE PICC	Aug 24, 2006	Substantially Equivalent	ARROW INTERNATIONAL, INC.
K061936	KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311	Aug 09, 2006	Substantially Equivalent	THE KENDALL COMPANY
K061179	POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER	Aug 09, 2006	Substantially Equivalent	C.R. BARD, INC.
K061986	1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50	Aug 03, 2006	Substantially Equivalent	MEDCOMP
K061240	SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES	Jun 02, 2006	Substantially Equivalent	LUCENT MEDICAL SYSTEMS
K060887	ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT	Apr 28, 2006	Substantially Equivalent	ANGIODYNAMICS, INC.
K053345	PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D	Mar 17, 2006	Substantially Equivalent	MEDCOMP
K053501	POWERPICC	Jan 13, 2006	Substantially Equivalent	BARD ACCESS SYSTEMS, INC.
K051672	POWERPICC	Nov 23, 2005	Substantially Equivalent	BARD ACCESS SYSTEMS, INC.
K051102	OMNIPICC PI	Nov 23, 2005	Substantially Equivalent	RITA MEDICAL SYSTEMS, INC.
K051991	POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE	Oct 20, 2005	Substantially Equivalent	C.R. BARD, INC.
K050889	FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH	Aug 26, 2005	Substantially Equivalent	CRS MEDICAL DIAGNOSTICS INC.
K051690	VYGON NUTRILINE CATHETERS	Aug 19, 2005	Substantially Equivalent	VYGON CORP.
K050542	MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER	Jul 26, 2005	Substantially Equivalent	MARIAN MEDICAL, INC.
K051194	BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669	Jul 25, 2005	Substantially Equivalent	BECTON DICKINSON & CO.
K041849	TURBO-FLO PICC	Jul 21, 2005	Unknown	COOK, INC.
K051417	6 FR FL POWERHOHN AND POWERLINE CATHETER	Jun 30, 2005	Substantially Equivalent	C.R. BARD, INC.
K050931	6 FR DL POWERPICC CATHETER	Jun 15, 2005	Substantially Equivalent	C.R. BARD, INC.
K050185	POWERHOHN AND POWERLINE CATHETERS	May 26, 2005	Substantially Equivalent	C.R. BARD, INC.
K043502	6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC	Jan 14, 2005	Substantially Equivalent	C.R. BARD, INC.
K030400	NEOSCI MEDICAL ENDOLUMINAL BRUSH	Dec 22, 2004	Substantially Equivalent	NEOSCI MEDICAL, INC.
K042461	KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304	Dec 10, 2004	Substantially Equivalent	KENDALL
K042491	BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER	Nov 22, 2004	Substantially Equivalent	BECTON DICKINSON & CO.
K041088	TRIFUSION, MODEL 0609190/0659350	Nov 01, 2004	Substantially Equivalent	C.R. BARD, INC.
K041468	PREMICATH, 1261.205	Sep 09, 2004	Substantially Equivalent	VYGON CORP.
K042126	PICC	Aug 27, 2004	Unknown	ARROW INTL., INC.
K041420	ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT	Jul 26, 2004	Substantially Equivalent	ANGIODYNAMICS, INC.
K033389	POWERPICC CATHETERS, MODELS 3175155, 3175135	Mar 19, 2004	Substantially Equivalent	C.R. BARD, INC.
K040446	ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT	Mar 05, 2004	Substantially Equivalent	ANGIODYNAMICS, INC.
K034020	GROSHONG NXT PICC CATHETERS	Jan 21, 2004	Substantially Equivalent	C.R. BARD, INC.
K034019	POLY PER-Q-CATH PICC CATHETERS	Jan 21, 2004	Substantially Equivalent	C.R. BARD, INC.
K031718	LIFEVALVE CENTRAL VENOUS CATHTER	Jul 02, 2003	Substantially Equivalent	HORIZON MEDICAL PRODUCTS, INC.
K031626	ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT	Jun 19, 2003	Substantially Equivalent	ANGIODYNAMICS, INC.
K031129	POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC	May 05, 2003	Substantially Equivalent	C.R. BARD, INC.
K030415	ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT	Apr 30, 2003	Substantially Equivalent	ANGIODYNAMICS, INC.
K030270	3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON	Apr 11, 2003	Substantially Equivalent	MEDCOMP
K030255	SILICONE DUAL LUMEN RADPICC CATHETERS	Feb 07, 2003	Substantially Equivalent	C.R. BARD, INC.
K023374	GROSHONG NXT DUAL LUMEN PICC CATHETERS	Dec 18, 2002	Substantially Equivalent	C.R. BARD, INC.
K021704	VAXCEL PICC WITH PASV VALVE TECHNOLOGY	Jun 06, 2002	Substantially Equivalent	CATHETER INNOVATIONS, INC.
K012641	FAS ENDOLUMINAL BRUSH	Oct 15, 2001	Substantially Equivalent	FAS MEDICAL LTD.
K012902	POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100	Sep 10, 2001	Substantially Equivalent	C.R. BARD, INC.
K003839	CENTRAL VENOUS CATHETER	Aug 01, 2001	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K010349	DUAL LUMEN MIDLINE CATHETER	Feb 28, 2001	Substantially Equivalent	CATHETER INNOVATIONS, INC.
K003682	MEDCOMP Z-CATH	Jan 26, 2001	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K992424	SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20	Dec 29, 2000	Substantially Equivalent	PLASTIMED LABORATOIRE PHARMACEUTIQUE
K003642	PLACEMENT-PLUS	Dec 20, 2000	Substantially Equivalent	CATHETER INNOVATIONS, INC.
K003110	MEDCOMP BIO-CATH CATHETER LINE	Dec 01, 2000	Substantially Equivalent	MEDCOMP
K001874	PERIPHERALLY INSERTED CENTRAL CATHETER	Sep 25, 2000	Substantially Equivalent	UTAH MEDICAL PRODUCTS, INC.
K001901	POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135	Sep 19, 2000	Substantially Equivalent	C.R. BARD, INC.
K993442	VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)	Aug 03, 2000	Substantially Equivalent	VYGON CORP.
K993052	VYGON 2 FR EPICUTANEO PUR-CATHETER	Aug 03, 2000	Substantially Equivalent	VYGON CORP.
K993614	FAS ENDOLUMINAL BRUSH	Jan 18, 2000	Substantially Equivalent	FAS MEDICAL LTD.
K983544	VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)	Jan 13, 1999	Substantially Equivalent	VYGON CORP.
K983412	MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T	Dec 10, 1998	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K980090	ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)	Mar 24, 1998	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K972555	CATHETER TUNNELER	Dec 22, 1997	Substantially Equivalent	GERARD MEDICAL, INC.
K971999	PERIPHERALLY INSERTED CENTRAL	Nov 24, 1997	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K973057	1.4 FR MAPCATH SENSOR STYLET	Nov 12, 1997	Substantially Equivalent	NAVION BIOMEDICAL CORP.
K970926	DOUBLE LUMEN PICC	Aug 01, 1997	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K970269	CLINICATH IR PERIPHERALLY INSERTED CATHETER	Jun 26, 1997	Substantially Equivalent	SIMS DELTEC, INC.
K971085	SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER	Jun 02, 1997	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K964929	PERIPHERALLY INSERTED CENTRAL CATHETER	Jun 02, 1997	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K964556	HR POLYURETHANE PICC AND MIDLINE CATHETERS	Apr 16, 1997	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K964447	PICC CATHETER/MIDLINE CATHETER	Apr 16, 1997	Substantially Equivalent	MENLO CARE, INC.
K970434	NEO-PICC	Apr 01, 1997	Substantially Equivalent	KLEIN-BAKER MEDICAL, INC.
K963257	PERIPHERALLY INSERTED MEDLINE CATHETER	Mar 04, 1997	Substantially Equivalent	ARROW INTL., INC.
K963806	CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)	Dec 12, 1996	Substantially Equivalent	BMW MEDICAL, INC.
K963215	CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)	Nov 14, 1996	Substantially Equivalent	BMW MEDICAL, INC.
K963097	CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)	Oct 18, 1996	Substantially Equivalent	BMW MEDICAL, INC.
K962849	CATHETER INSERTION TRAY	Oct 07, 1996	Substantially Equivalent	MEDCARE MEDICAL GROUP, INC.
K960055	MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932	Sep 30, 1996	Substantially Equivalent	PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K962300	CLAMPLESS VALVED CATHETER	Sep 05, 1996	Substantially Equivalent	BMW MEDICAL, INC.
K961856	AUTO SUTURE CHEMOSITE TUNNELER	Jul 18, 1996	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K961336	MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652	Jul 18, 1996	Substantially Equivalent	MEDTRONIC PS MEDICAL
K961155	SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908	Jun 18, 1996	Substantially Equivalent	DOUGLAS MEDICAL PRODUCTS CORP.
K954302	VYGON PREMI-CATH - LONG TERM CATHETER	Jun 17, 1996	Substantially Equivalent	VYGON CORP.
K953300	V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER	Apr 30, 1996	Substantially Equivalent	HDC CORP.
K954638	5 FR PICC-LINE CATHETER	Apr 22, 1996	Substantially Equivalent	VYGON CORP.
K954720	STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS	Jan 04, 1996	Substantially Equivalent	STRATO/INFUSAID, INC.
K954409	PS MEDICAL IPI VASCULAR ACCESS CATHETER	Dec 18, 1995	Substantially Equivalent	PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K954422	PER-Q-CATH MID-LINE	Dec 15, 1995	Substantially Equivalent	GESCO INTL., INC.
K954104	PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES	Nov 21, 1995	Substantially Equivalent	C.R. BARD, INC.
K953436	STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM	Oct 04, 1995	Substantially Equivalent	STRATO/INFUSAID, INC.
K953256	STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS	Oct 04, 1995	Substantially Equivalent	STRATO/INFUSAID, INC.
K952626	MAPWIRE J-TIP SENSOR GUIDEWIRE	Aug 25, 1995	Substantially Equivalent	NAVION BIOMEDICAL CORP.
K951078	CATHETER, INTRAVASCULAR OR PERCUTANEOUS	Jul 31, 1995	Substantially Equivalent	SIMS DELTEC, INC.
K945956	STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS	Jun 06, 1995	Substantially Equivalent	STRATO MEDICAL CORP.
K951098	HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER	Jun 02, 1995	Substantially Equivalent	HDC CORP.
K950987	STRATO/INFUSAID TUNNELER	Jun 02, 1995	Substantially Equivalent	STRATO/INFUSAID, INC.
K946250	STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS	May 02, 1995	Unknown	STRATO MEDICAL CORP.
K944685	CATO FIRST PICC-DUAL LUMEN	Mar 31, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K935145	CYPERFLO PERIPHERALLY INSERTED CATHETER	Mar 09, 1995	Substantially Equivalent	CYEX MEDICAL TECHNOLOGIES, INC.
K935380	VASCULAR ACCESS CATHETER ACCESSORIES	Feb 17, 1995	Substantially Equivalent	BARD ACCESS SYSTEMS, INC.
K945499	CATO FIRST PICC KIT	Feb 07, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K932464	PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.	May 02, 1994	Unknown	PHARMACIA DELTEC, INC.
K932433	PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE	May 02, 1994	Unknown	PHARMACIA DELTEC, INC.
K932430	DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER	May 02, 1994	Unknown	PHARMACIA DELTEC, INC.
K932211	PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS	May 02, 1994	Substantially Equivalent	PHARMACIA DELTEC, INC.
K932198	PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH	May 02, 1994	Unknown	PHARMACIA DELTEC, INC.
K930473	ONECATH L-CATH CATHETER SYSTEM	Apr 07, 1994	Unknown	LUTHER MEDICAL PRODUCTS, INC.
K930129	ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER	Mar 28, 1994	Unknown	ARROW INTL., INC.
K925236	L CATH(R) CATHETER SYSTEM	Mar 22, 1994	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K926331	3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH	Mar 07, 1994	Unknown	BARD ACCESS SYSTEMS, INC.
K926293	ANGIOCOR SIDEHOLE INFUSION CATHETER	Mar 07, 1994	Substantially Equivalent	ANGIOCOR
K930630	RIGHT ATRIAL CATHETER	Feb 07, 1994	Substantially Equivalent for Some Indications	AKCESS MEDICAL PRODUCTS, INC.
K933884	STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM	Dec 30, 1993	Unknown	STRATO MEDICAL CORP.
K924851	STRATO MEDICAL SINGLE LUMEN VALVED CATHETER	Dec 13, 1993	Unknown	STRATO MEDICAL CORP.
K924677	STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH	Jul 30, 1993	Unknown	STRATO MEDICAL CORP.
K921751	INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER	Jul 07, 1993	Unknown	STRATO MEDICAL CORP.
K920755	L-CATH PEEL AWAY SYSTEM CATHETER	Jun 07, 1993	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K923653	NEEDLELESS INJECTION CANNULA	May 13, 1993	Substantially Equivalent	ARROW INTL., INC.
K921755	8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS	Oct 23, 1992	Substantially Equivalent	DAVOL, INC.
K911067	NORCATH VASCULAR ACCESS CATHETERS	Jun 03, 1991	Substantially Equivalent	NORFOLK MEDICAL
K910486	8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER	Apr 19, 1991	Substantially Equivalent	DAVOL, INC.
K910315	PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K	Apr 05, 1991	Unknown	SOREX MEDICAL
K910622	GESCO PER-Q-CATH REPAIR KIT	Mar 29, 1991	Unknown	GESCO INTL., INC.
K903648	VYGON LIFEVAC PICC	Mar 07, 1991	Unknown	VYGON CORP.
K904334	PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT	Nov 05, 1990	Unknown	PHARMACIA DELTEC, INC.
K895543	WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER	Sep 21, 1990	Substantially Equivalent	STRATO MEDICAL CORP.
K896598	STRATO INDWELLING CATHETER	Apr 25, 1990	Substantially Equivalent	STRATO MEDICAL CORP.
K897168	EPICUTANEO-CAVA CATHETER CODE 2184	Apr 23, 1990	Unknown	VYGON CORP.
K895712	PERCUTANEOUS INTRAVENOUS CATHETERS	Dec 15, 1989	Substantially Equivalent	PHARMACIA DELTEC, INC.
K892926	DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS	Dec 05, 1989	Substantially Equivalent	VAS-CATH, INC.
K893126	DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE	Aug 10, 1989	Unknown	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K883313	PMT VASCULAR CATHETER MODEL NUMBER 3621-1	Oct 04, 1988	Substantially Equivalent	PMT CORP.
K882448	MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE	Aug 09, 1988	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K882100	VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT	Jul 13, 1988	Substantially Equivalent	VITAPHORE CORP.
K871998	GROSHONG CV CATHETER REPAIR KIT	Jun 24, 1987	Substantially Equivalent	CATHETER TECHNOLOGY CORP.
K864086	VAPOR-SEAL(TM) PERCUTANEOUS CATHETERS	Apr 03, 1987	Substantially Equivalent	PHARMACIA, INC.
K861563	VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT	Aug 27, 1986	Substantially Equivalent	VITAPHORE CORP.
K851243	GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION	Mar 14, 1986	Substantially Equivalent	COOK, INC.
K851195	VASCULAR ACCESS CATHETER	Jun 07, 1985	Substantially Equivalent	SIL-MED CORP.
K844080	ARROW-GEISS PERCUTANEOUS TPN KIT	Apr 17, 1985	Substantially Equivalent	ARROW INTL., INC.
K843450	ARGYLE SILICONE CENTRAL VENOUS CATH-	Nov 15, 1984	Substantially Equivalent	SHERWOOD MEDICAL CO.
K841443	REDO CENTRAL VENOUS CATHETER-NEONATE	Jul 27, 1984	Substantially Equivalent	INTL. HOSPITAL PRODUCTS, INC.
K841878	SHEATH REMOVER	Jul 13, 1984	Substantially Equivalent	DATASCOPE CORP.
K840742	RIGHT ATRIAL CATHETER	Jul 13, 1984	Substantially Equivalent	THE HEALTHCARE GROUP LABORATORIES, INC.
K840846	STERILE HICHMAN/BROVIAC INJECTION CAP	Jul 06, 1984	Substantially Equivalent	EVERMED, INC.
K834383	DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT	May 01, 1984	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K834299	LONG TERM CENTRAL VENOUS ACCESS CATH	May 01, 1984	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K834473	MULTI-LUMEN CENTRAL VENOUS CATH. KIT	Apr 30, 1984	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K840958	DESERET LONG TERM INDWELLING CATHETER	Apr 17, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K840681	DAYPAK SYSTEM III CATHETER CARE KIT	Apr 16, 1984	Substantially Equivalent	CREATIVE CARE SYSTEMS, INC.
K833915	VASCULAR ACCESS CATH. REPAIR KIT	Mar 30, 1984	Substantially Equivalent	CORMED, INC., SUB. C.R.BARD, INC.
K833442	PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM	Mar 19, 1984	Substantially Equivalent	QUINTON, INC.
K834091	SILCATH	Mar 06, 1984	Substantially Equivalent	HDC CORP.
K834225	RAAF DUAL LUMEN CATH. REPAIR KIT 2.2	Feb 13, 1984	Substantially Equivalent	QUINTON, INC.
K831802	LIFE VAC #2191 & 2192	Jan 11, 1984	Substantially Equivalent	EXCO, INC.
K832774	REPAIR KITS FOR RIGHT ATRIAL CATH	Jan 03, 1984	Substantially Equivalent	QUINTON, INC.
K832580	RAAF CATHETER REPAIR KIT	Jan 03, 1984	Substantially Equivalent	QUINTON, INC.
K831587	TEMP. REPAIR KIT-DUAL LUMEN CATHETER	Oct 19, 1983	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K831386	GROSHONG CATHETER, LONG TERM TYPE	Oct 14, 1983	Substantially Equivalent	CATHETER TECHNOLOGY CORP.
K831845	PER-Q-CATH TRAY	Aug 24, 1983	Substantially Equivalent	GESCO INTL., INC.
K830969	PERM. REPAIR KIT FOR LEONARD NORTON DUAL	Apr 14, 1983	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K830406	NON-STERILE CATHETER REPAIR KITS	Mar 01, 1983	Substantially Equivalent	EVERMED, INC.
K830256	NON-STERILE BROVIAC PARENTERAL ALIMI-	Mar 01, 1983	Substantially Equivalent	EVERMED, INC.
K830233	NON-STERILE,SINGLE/SOUBLE LUMEN-CATH	Feb 28, 1983	Substantially Equivalent	EVERMED, INC.
K823553	CORCATH H & B VASCULAR ACCESS CATHETER	Jan 05, 1983	Substantially Equivalent	CORMED, INC., SUB. C.R.BARD, INC.

FEI Numbers

This FDA classification entry is associated with 89 FEI numbers. Click on an entry to view related FDA registrations.

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1319211: 63 registrations

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