Product Code: KOC FDA class 2 21 CFR 876.5820

Accessories, Blood Circuit, Hemodialysis

Gastroenterology, Urology

Hemodialysis Blood Circuit Accessories are components used as part of the extracorporeal blood circuit in hemodialysis systems, including tubing, connectors, blood pumps, and pressure monitors that facilitate the circulation of blood outside the body during renal dialysis treatment. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KOC and it is regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is classified as life-sustaining or life-supporting.

View on FDA

510(k)s

182

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KOC
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
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 182 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242479	BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU	May 15, 2025	Substantially Equivalent	NIKKISO CO., LTD.
K242176	BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)	May 15, 2025	Substantially Equivalent	NIKKISO CO., LTD.
K231589	Blood Tubing Lines for Hemodialysis AV06C-E	Jul 28, 2023	Substantially Equivalent	NIKKISO CO., LTD.
K230514	Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series	Jun 16, 2023	Substantially Equivalent	NIKKISO CO., LTD.
K201207	CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line	Sep 18, 2020	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K172238	CAREline Airless Hemodialysis Blood Tubing Sets	Dec 14, 2017	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K160749	CRIT-LINE III Blood Chamber II	Apr 15, 2016	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K152953	CRIT-LINE CLIP (CLIC) BLOOD CHAMBER	Nov 05, 2015	Substantially Equivalent	Fresenius Medical Care North America
K141997	CRIT-LINE IV SYSTEM	Apr 01, 2015	Substantially Equivalent	Fresenius Medical Care
K141281	CRIT-LINE CLIP (CLIC) BLOOD CHAMBER	Aug 14, 2014	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K121599	CRIT-LINE CLIP (CLIC)	Nov 09, 2012	Substantially Equivalent	Fresenius Medical Care-North America
K082719	NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P	Mar 30, 2009	Substantially Equivalent	NIKKISO CO., LTD.
K081740	HEMOBAND, MODELS HB-NS AND HB-NSXL	Mar 12, 2009	Substantially Equivalent	Innovations For Access, Inc.
K082758	PRISMAFLO II	Dec 19, 2008	Substantially Equivalent	Stihler Electronic GmbH
K081043	LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT	Jul 07, 2008	Substantially Equivalent	Nxstage Medical, Inc.
K071909	PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R	Oct 18, 2007	Substantially Equivalent	Barkey GmbH & Co. KG
K030456	VASC-ALERT	Jul 11, 2003	Substantially Equivalent	Vasc-Alert, LLC
K022536	\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR	Oct 30, 2002	Substantially Equivalent	Fresenius Medical Care
K020103	PRISMAFLO	Jul 24, 2002	Substantially Equivalent	Stihler Electronic GmbH
K003712	MODIFICATION TO MALE TO MALE LUER ADAPTER	May 16, 2001	Substantially Equivalent	Molded Products, Inc.
K010268	FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9	Apr 27, 2001	Substantially Equivalent	Fresenius Medical Care North America
K002816	TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV	Nov 22, 2000	Substantially Equivalent	Transonic Systems, Inc.
K002372	ACCESS ALERT GAUGE	Oct 25, 2000	Substantially Equivalent	Medisystems Corp.
K994306	REVERSO	Mar 20, 2000	Substantially Equivalent	Medisystems Corp.
K983707	JMS DIALYZER PRIMING SET	Jan 08, 1999	Substantially Equivalent	Jms Co., Ltd.
K972206	NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS	Nov 26, 1997	Substantially Equivalent	Nipro Medical Corp.
K971860	MEDISYSTEMS DIALYSIS PRIMING SETS	Aug 18, 1997	Substantially Equivalent	Medisystems Corp.
K954676	NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS	Mar 04, 1997	Substantially Equivalent	Nissho Corp.
K964041	CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS	Jan 30, 1997	Substantially Equivalent	Robert R. Stevens
K955277	ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS	Feb 16, 1996	Substantially Equivalent	Baxter Healthcare Corp
K952572	DIALYSIS ADMINISTRATION KITS	Jan 11, 1996	Substantially Equivalent	B.Braun Medical, Inc.
K950282	KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA	Apr 05, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K941851	DUAL LUMEN CATHETER (DLC) TRAY	Mar 13, 1995	Substantially Equivalent	Neostar Medical Technologies, Inc.
K941543	DIAL MEDICAL KIT	Feb 16, 1995	Unknown	Regulatory & Marketing Services, Inc.
K941803	PRISM MEDICAL CUSTOM DIALYSIS KIT	Jan 30, 1995	Unknown	Medical Device Support Services
K935958	CRIT-LINE BLOOD CHAMBER WITH E-BEAM	Jan 19, 1995	Substantially Equivalent	In-Line Diagnostics Corp.
K926374	SILICONE CATHETER REPAIR KITS	Oct 07, 1994	Unknown	Akcess Medical Products, Inc.
K925522	CENTRYSYSTEM 3 WITH CHARTS/BP OPTION	Sep 30, 1994	Substantially Equivalent	C.G.H. Medical, Inc.
K925654	CD HOME DIALYSERVICE HEMODIALYSIS TRAY	Mar 30, 1994	Unknown	Cd Medical, Inc.
K924436	BARD UROTRACK II MONITORING	Mar 15, 1994	Substantially Equivalent	C.R. Bard, Inc.
K911230	RS-1000	Jun 09, 1993	Substantially Equivalent	Cp Medical
K920671	DIGI -FLOW	Jan 28, 1993	Substantially Equivalent	D and D Technology, Inc.
K920614	HEMO-BAND	Jul 27, 1992	Substantially Equivalent	Innovations IN Access, Inc.
K912374	BARD(R) UROTACK(R) 210 MONITORING SYSTEM	Mar 31, 1992	Substantially Equivalent	C.R. Bard, Inc.
K913361	DRAIN/PRIMING/RECIRCULATION BAG	Mar 30, 1992	Substantially Equivalent	Haemotronic, Inc.
K911315	EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT	Oct 30, 1991	Substantially Equivalent	Baxter Healthcare Corp
K913483	MINNILERT(R) PRESSURE MONITOR	Sep 27, 1991	Substantially Equivalent	Minntech Corp.
K911106	MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG	May 28, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910641	INTRODUCER NEEDLES	Apr 29, 1991	Substantially Equivalent	Akcess Medical Products, Inc.
K910321	Y ADAPTOR	Apr 16, 1991	Substantially Equivalent	Akcess Medical Products, Inc.
K902588	BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD	Mar 07, 1991	Substantially Equivalent	Gambro-Hospal, Inc.
K900306	HEMODIALYSIS BLOOD LINES	Apr 20, 1990	Substantially Equivalent	Gainor Medical Europe, Ltd.
K895244	MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.	Feb 12, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K895882	JMS DIALYZER PRIMING SET	Feb 09, 1990	Substantially Equivalent	Jms Co., Ltd.
K896006	DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095	Dec 27, 1989	Substantially Equivalent	Baxter Healthcare Corp
K894637	NATIONAL MEDICAL CARE VENOUS LINE 03-9548	Sep 22, 1989	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K853555	FAST FORMALERT	Jun 26, 1986	Substantially Equivalent	Organon Teknika Corp.
K852135	BSM 21 BLOOD SAFETY MODULE	Jun 12, 1985	Substantially Equivalent	Hospal Medical Corp.
K852134	BSM 22 BLOOD SAFETY MODULE	Jun 12, 1985	Substantially Equivalent	Hospal Medical Corp.
K844504	SARTORIUS MINISART SM 16596HY	Jan 18, 1985	Substantially Equivalent	Sartorius Filters, Inc.
K844185	MODIFIED C-DAK	Jan 03, 1985	Substantially Equivalent	Cd Medical, Inc.
K843531	ASN MONITOR SINGLE NEEDLE MONITOR	Nov 16, 1984	Substantially Equivalent	Organon Teknika Corp.
K843632	HOLLOW FIBER DIALYZER	Oct 18, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K840937	CAPILLARY FLOW DIALYZERS	Sep 12, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K840845	HOLLOW FIBER DIALYZERS	Aug 16, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K842436	ERIKA NEGATIVE PRESS. ARTERIAL BLOOD	Jul 13, 1984	Substantially Equivalent	Erika, Inc.
K831176	FILTRYZER HOLLOW FIBER ARTIF. KIDNEY	Jun 22, 1984	Substantially Equivalent	Erika, Inc.
K831175	FILTRYZER HOLLOW FIBER ARTIF. KIDNEY	Jun 22, 1984	Substantially Equivalent	Erika, Inc.
K831174	FILTRYZER HOLLOW FIBER ARTIFICIAL KID-	Jun 22, 1984	Substantially Equivalent	Erika, Inc.
K831173	TORAY INDUSTRIES FILTRYZER HOLLOW FIBER	Jun 22, 1984	Substantially Equivalent	Erika, Inc.
K840859	MAKS CENTRAL DELIVERY SYS-11-200 ETC	May 22, 1984	Substantially Equivalent	Erika, Inc.
K840654	DIALYSIS ADMIN. SET - I.V.	May 02, 1984	Substantially Equivalent	Cp Medical
K841124	DIALYSIS TRAY	Apr 20, 1984	Substantially Equivalent	Medcare Products
K840062	BSM 2000 DIALYSIS MACHINE	Mar 22, 1984	Substantially Equivalent	Organon Teknika Corp.
K840146	EXP* 700 PARALLEL PLATE DIALYZER	Feb 04, 1984	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K840057	EXP* 500 PARALLEL PLATE DIALYZER	Feb 04, 1984	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K834596	BLOOD TUBING	Feb 04, 1984	Substantially Equivalent	Renal Systems, Inc.
K833906	NEGATIVE PRESSURE VENOUS BLOOD LINE	Jan 03, 1984	Substantially Equivalent	Erika, Inc.
K833905	NEGATIVE PRESSURE ARTERIAL BLOOD	Jan 03, 1984	Substantially Equivalent	Erika, Inc.
K833896	BICARBOLYTE HEMO-DIAL	Jan 03, 1984	Substantially Equivalent	Edlaw Pharmaceuticals, Inc.
K833308	DUAL LUMEN NEEDLE	Dec 27, 1983	Substantially Equivalent	Quinton, Inc.
K833252	ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF	Dec 14, 1983	Substantially Equivalent	Erika, Inc.
K833503	CLIRANS MODEL TAF 15 HOLLOW FIBER	Dec 08, 1983	Substantially Equivalent	Terumo Medical Corp.
K833440	BLOOD SAFETY MODULE BSM2	Dec 08, 1983	Substantially Equivalent	Hospal Medical Corp.
K833653	D-LYTE	Nov 28, 1983	Substantially Equivalent	Dialysis Products, Inc.
K832925	MODIFICATION IN MEMBRANE HOUSING CONFI	Nov 28, 1983	Substantially Equivalent	Ries Biologicals
K833150	ASAHI HOLLOW FIBER KIDNEYS, EXCEL	Nov 15, 1983	Substantially Equivalent	Asahi Medical Co., Ltd.
K832894	LUNDIA 10-2-L PARALLEL PLATE HEMODIALY	Oct 14, 1983	Substantially Equivalent	Gambro, Inc.
K832666	NEPHROSS PRESTO	Oct 14, 1983	Substantially Equivalent	Organon Teknika Corp.
K832623	TOP DISPOS. INFUSION SET/HEMODIALY	Oct 14, 1983	Substantially Equivalent	Top Surgical Manufacturers Co.
K832053	SINGLE PATIENT SYS. II MODEL DM-450	Sep 29, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K831663	TISSUE FORCEPS	Sep 26, 1983	Substantially Equivalent	Medcare Products
K832252	CLIRANS TAF06 HOLLOW FIBER DIALYZER	Aug 26, 1983	Substantially Equivalent	Terumo Medical Corp.
K832103	BLOOD TUBING SET	Aug 12, 1983	Substantially Equivalent	Lee Medical Intl., Inc.
K831770	ARTIFICIAL KIDNEY BLOOD CIRCUIT	Jul 07, 1983	Substantially Equivalent	Eiken Kizai Co., Ltd.
K831409	HAEMOLYTE SOLUTION	Jun 30, 1983	Substantially Equivalent	Dialysis Clinic, Inc.
K831606	GF-180-L HOLLOW FIBER HEMODIALYSIS	Jun 24, 1983	Substantially Equivalent	Gambro, Inc.
K831482	CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &	Jun 03, 1983	Substantially Equivalent	Terumo Medical Corp.
K831376	CDS 2001 ARTIFICIAL KIDNEY	Jun 03, 1983	Substantially Equivalent	Elmar Medical Systems, Ltd.
K831433	EXTRASENSR ULTRAFILTRATION MONITOR	Jun 02, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K831338	LUNDIA 10-3-L PARALLEL FLOW DIALYZER	May 27, 1983	Substantially Equivalent	Gambro, Inc.
K830905	LUNDIA 10-2-N PARALLEL FLOW DIALYZER	Apr 06, 1983	Substantially Equivalent	Gambro, Inc.
K830729	C-DAK ARTIFICIAL KIDNEY	Mar 29, 1983	Substantially Equivalent	Cordis Corp.
K830291	WAK WEARABLE ARTIFICIAL KIDNEY	Mar 29, 1983	Substantially Equivalent	Wak-Utah
K823839	AMPCO KIDNEY DIALYSIS TRAY	Mar 29, 1983	Substantially Equivalent	Associated Medical Products Co.
K830231	ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES	Mar 17, 1983	Substantially Equivalent	Advocacy International, Ltd.
K830183	ASAHI HOLLOW FIBER KIDNEYS NR SERIES	Mar 17, 1983	Substantially Equivalent	Advocacy International, Ltd.
K822339	KF-101-13 DIALYZER	Feb 16, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K822338	KF-101-10 DIALYZER	Feb 16, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K822337	KF-101-07 DIALYZER	Feb 16, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K823715	SINGLE ACCESS DEVICE (SSAD)	Feb 07, 1983	Substantially Equivalent	Samaritan Hospital
K823068	MEDISYSTEMS FISTULA NEEDLES	Jan 26, 1983	Substantially Equivalent	Medisystems Corp.
K823069	KF-E SERIES HOLLOW FIBER DIALYZER	Jan 21, 1983	Substantially Equivalent	Medisystems Corp.
K830021	A.V. FISTULA CANNULATION SETS	Jan 14, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K823733	EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR	Jan 14, 1983	Substantially Equivalent	Advocacy International, Ltd.
K823826	CAPILLARY FLOW DIALYZERS	Jan 12, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K823791	LUNDIA 10-5-L PARRALLE FLOW DIALYZER	Jan 12, 1983	Substantially Equivalent	Gambro, Inc.
K823778	GAMMA STERILIZED CAPILLARY FLOW DIALYZ	Jan 07, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K823707	HOSPAL BLOOD LINES	Jan 05, 1983	Substantially Equivalent	Hospal Medical Corp.
K823546	RENAFLO II	Dec 16, 1982	Substantially Equivalent	Renal Systems, Inc.
K823375	NEPHROSS, ANDANTE H.F.	Dec 07, 1982	Substantially Equivalent	Organon Teknika Corp.
K822340	EXTRACORPOREAL SINGLE NEEDLE MODULE	Nov 03, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K822796	NEGATIVE PRESSURE ARTERIAL BLOOD LINE	Oct 18, 1982	Substantially Equivalent	Erika, Inc.
K822738	TRIEX-IH DIALYZER	Sep 24, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K822244	NEPHROSOL	Sep 02, 1982	Substantially Equivalent	Dialysis Systems, Inc.
K822283	TS-000 ARTERIOVENOUS BLOOD TUBING SET	Aug 27, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K822226	ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN	Aug 16, 1982	Substantially Equivalent	Erika, Inc.
K822225	ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE	Aug 16, 1982	Substantially Equivalent	Erika, Inc.
K822049	LUNDIA 10-5 N PARALLEL FLOW DIALYZER	Aug 16, 1982	Substantially Equivalent	Gambro, Inc.
K821367	GF-180-M & GF-180-H HEMODIALYZERS	May 28, 1982	Substantially Equivalent	Gambro, Inc.
K821495	DISPOSABLE BLOOD LINE CONNECTORS	May 27, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K812498	CLIRANS TE12 HOLLOW FIBER DIALYZER	Sep 29, 1981	Substantially Equivalent	Terumo Medical Corp.
K811981	ISOLATER THP	Aug 04, 1981	Substantially Equivalent	Tri-Med, Inc.
K811977	HEMASITE ACCESS MONITOR (TENT.) #RS-8200	Jul 31, 1981	Substantially Equivalent	Renal Systems, Inc.
K811457	MODEL RS-8100	Jun 23, 1981	Substantially Equivalent	Rinal Systems, Inc.
K810480	SCANLAN SUTURE BOOTS	Mar 13, 1981	Substantially Equivalent	Scanlan Intl., Inc.
K810074	ACCUFLO 100	Mar 04, 1981	Substantially Equivalent	Renal Care Corp.
K801356	BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET	Jul 08, 1980	Substantially Equivalent	Cordis Corp.
K801355	BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR	Jul 08, 1980	Substantially Equivalent	Cordis Corp.
K801354	BIONICS ARTERIAL/VENOUS FISTULA NEEDLE	Jul 08, 1980	Substantially Equivalent	Cordis Corp.
K792277	MODEL 7620 LINE CLAMP	Jan 16, 1980	Substantially Equivalent	B-D Drake Willock
K791411	COAXIAL DUAL FLOW CATHETER	Nov 13, 1979	Substantially Equivalent	Terumo America, Inc.
K790841	TG 2, TRI-GARD PRESSURE MONITOR	Jun 27, 1979	Substantially Equivalent	Sorensen Research
K790591	HEMODIALYSIS BLOOD CIRCUIT	May 02, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K790381	ARTERIOVENOUS SETS	Apr 20, 1979	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K781050	DLC 500, DOUBLE LUMEN CATHETER	Sep 26, 1978	Substantially Equivalent	Hemodialysis, Division of The
K771424	TUBE OCCLUDING FORCEPS	Aug 26, 1977	Substantially Equivalent	Quinton, Inc.
K770691	GAMBRO VENOUS BLOOD LINE	Apr 28, 1977	Substantially Equivalent	Gambro, Inc.
K770482	CATHETER, SINGLE PUNCTURE Y	Apr 15, 1977	Substantially Equivalent	Mdl Medical Device Laboratories, Inc.
K770552	CATHETER, KIDNEY DIALYSIS, HEMO-CATH II	Mar 30, 1977	Substantially Equivalent	Medical Disposables Intl., Inc.
K770524	TRANSDUCER PROTECTOR, RT-901, RT-902	Mar 30, 1977	Substantially Equivalent	Renal Systems, Inc.
K770475	PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2	Mar 16, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K770382	NEEDLE, FISTULA, ERIKA	Mar 08, 1977	Substantially Equivalent	Erika, Inc.
K770383	STOPCOCK, ONE WAY	Mar 07, 1977	Substantially Equivalent	Cobe Laboratories, Inc.
K770213	BARIOR	Feb 07, 1977	Substantially Equivalent	Tri-Med, Inc.
K770048	DNC 162 VINCA-FLO	Jan 14, 1977	Substantially Equivalent	Sorensen Research
K770046	DNC 142 VINCA-FLO	Jan 14, 1977	Substantially Equivalent	Sorensen Research
K770045	DNC 152 VINCA-FLO	Jan 14, 1977	Substantially Equivalent	Sorensen Research
K770044	DNC 141 VINCA-FLO	Jan 14, 1977	Substantially Equivalent	Sorensen Research
K770043	DNC 161 VINCA-FLO	Jan 14, 1977	Substantially Equivalent	Sorensen Research
K760994	MONITOR LINE W/FILTER & NEEDLE	Jan 06, 1977	Substantially Equivalent	Dravon Medical, Inc.
K761051	BI-FLOW NEEDLE	Dec 30, 1976	Substantially Equivalent	Dws, Inc.
K761082	SINGLE NEEDLE HEMODIALYSIS (BFC-142)	Dec 06, 1976	Substantially Equivalent	Sorensen Research
K761081	SINGLE NEEDLE HEMODIALYSIS (BFC-161)	Dec 06, 1976	Substantially Equivalent	Sorensen Research
K761078	HEMO-CATH I, KIDNEY DIALYSIS CATHETER	Dec 06, 1976	Substantially Equivalent	Medical Disposables Intl., Inc.
K761038	SINGLE NEEDLE HEMODIALYSIS	Dec 06, 1976	Substantially Equivalent	Sorensen Research
K760935	WINGED FISTULA NEEDLE	Nov 19, 1976	Substantially Equivalent	Gambro, Inc.
K760665	FISTULA NEEDLE (#11-265)	Oct 21, 1976	Substantially Equivalent	Cobe Laboratories, Inc.
K760640	FILTER SET, PMF 1024	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760639	FILTER SET, PMF 2028	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760638	FILTER, PMF 1000	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760637	FILTER SET, PMF 1448	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760633	FILTER SET PMF 1028	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760632	FILTER SET PMF 2024	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760631	FILTER SET 1288	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760630	FILTER SET PMF 200	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760629	FILTER SET PMF 100	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760628	FILTER SET PMF 2448	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760627	FILTER SET PMF 2168	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760626	FILTER SET PMF 2288	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760625	FILTER SET PMF 1168	Oct 15, 1976	Substantially Equivalent	Sorensen Research
K760042	BLOOD TUBING SETS	Aug 30, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic