Product Code: KRA FDA class 2 21 CFR 870.1210

Catheter, Continuous Flush

Cardiovascular

This device is a continuous flush catheter used in cardiovascular monitoring to maintain patency of arterial or central venous lines by delivering a slow, continuous infusion of heparinized saline, preventing clot formation and ensuring accurate pressure readings. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRA, regulated under 21 CFR 870.1210 within the Cardiovascular specialty. This device is eligible for third-party review.

View on FDA

510(k)s

175

FEI Numbers

147

Registration Numbers

147

Unique Applicants

Years Active

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Basic Information

Product Code: KRA
Device Class: FDA class 2
Regulation Number: 870.1210
Medical Specialty: Cardiovascular
Review Panel: CV
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 175 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261610	Verge Microcatheter	Jun 11, 2026	Substantially Equivalent	Instylla, Inc.
K260771	TruSelect 2.6 Microcatheter	May 15, 2026	Substantially Equivalent	Boston Scientific Corporation
K250794	InVera Infusion Device	Mar 12, 2026	Substantially Equivalent	Invera Medical
K243534	Micro Catheter	Jul 30, 2025	Substantially Equivalent	Suzhou Zenith Vascular SciTech Limited
K231821	XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)	Nov 29, 2023	Substantially Equivalent	Transit Scientific, LLC
K231279	Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm	Jul 05, 2023	Substantially Equivalent	Ablative Solutions, Inc.
K231148	ScleroSafe 150 mm, ScleroSafe 350 mm	Jun 20, 2023	Substantially Equivalent	Vvt Medical , Ltd.
K230957	TriSalus TriNav® LV Infusion System	May 02, 2023	Substantially Equivalent	Trisalus Life Sciences
K223139	Wallaby 017 Micro Catheter	Apr 25, 2023	Substantially Equivalent	Wallaby Medical
K223176	Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister	Apr 10, 2023	Substantially Equivalent	Argon Medical Devices, Inc.
K230636	Maestro Microcatheter	Mar 30, 2023	Substantially Equivalent	Merit Medical System, Inc.
K222679	Vericor Support Catheter	Nov 07, 2022	Substantially Equivalent	Vascupatent Medical (Shenzhen) Co., Ltd.
K213435	MAGIC Flow-Dependent Microcatheter	Jul 19, 2022	Substantially Equivalent	Balt USA, LLC
K213442	Extroducer Infusion Catheter System	Jun 10, 2022	Substantially Equivalent	SmartWise Sweden AB
K214025	PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter	Apr 12, 2022	Substantially Equivalent	Medos International SARL
K212719	Micro Catheter and Guidewire System	Apr 11, 2022	Substantially Equivalent	Suzhou Hengrui Hongyuan Medical Co., Ltd.
K211110	Agile Devices Angler Steerable, Deflectable Microcatheter	Jan 07, 2022	Substantially Equivalent	Agile Devices, Inc.
K210838	PROWLER SELECT PLUS; PROWLER EX	Aug 25, 2021	Substantially Equivalent	Medos International SARL
K210339	Bullfrog Micro-Infusion Device	Aug 02, 2021	Substantially Equivalent	Mercator Medsystems, Inc.
K211525	SwiftNINJA Steerable Microcatheter	Jul 16, 2021	Substantially Equivalent	Merit Medical Systems, Inc.
K210808	Instylla Microcatheter 1.2	Apr 15, 2021	Substantially Equivalent	Instylla, Inc.
K210114	Rebar Micro Catheter	Feb 16, 2021	Substantially Equivalent	Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular
K202366	MAGIC Infusion Catheter	Jan 29, 2021	Substantially Equivalent	Balt USA, LLC
K202318	Marathon Flow Directed Micro Catheter	Sep 14, 2020	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K193082	Fountain ValveTip Infusion Catheter	Aug 07, 2020	Substantially Equivalent	Merit Medical Systems, Inc.
K201907	ClariVein IC	Aug 06, 2020	Substantially Equivalent	Merit Medical Systems, Inc.
K201792	TRUSELECT Microcatheter	Jul 28, 2020	Substantially Equivalent	Boston Scientific Corporation
K200582	Bendit2.7 Steerable Microcatheter	Jun 25, 2020	Substantially Equivalent	Bend IT Technologies, Ltd.
K200744	Instylla Microcatheter	Apr 21, 2020	Substantially Equivalent	Instylla, Inc.
K191305	Hereaeus Poseidon Microcatheter	Dec 19, 2019	Substantially Equivalent	Heraeus Medical Components, LLC
K193107	TriSalus Infusion System	Dec 03, 2019	Substantially Equivalent	Trisalus Life Sciences
K191731	Instylla Microcatheter	Aug 13, 2019	Substantially Equivalent	Instylla, Inc.
K182071	Multi-Sideport Catheter Infusion Set	Apr 25, 2019	Substantially Equivalent	Cook Incorporated
K181684	VAMP Plus Venous/Arterial Blood Management Protection System	Nov 08, 2018	Substantially Equivalent	Edwards Lifesciences, LLC
K180275	VAMP Optima closed blood sampling system	Oct 24, 2018	Substantially Equivalent	Edwards Lifesciences, LLC
K173586	VAMP Venous/Arterial Blood Management Protection System	Apr 05, 2018	Substantially Equivalent	Edwards Lifesciences, LLC
K171665	Microcatheter and guide-wire system	Jan 11, 2018	Substantially Equivalent	Suzhou Hengrui Disheng Medical Co., Ltd.
K170931	CXI TriForce Peripheral Crossing Set	Nov 13, 2017	Substantially Equivalent	Cook Incorporated
K172081	Maestro Microcatheter	Aug 04, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K163701	Direxion and Direxion HI-FLO Torqueable Microcatheters	May 16, 2017	Substantially Equivalent	Boston Scientific Corporation
K161967	FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm	Jan 27, 2017	Substantially Equivalent	Callisyn Biomedical, Inc.
K161962	VAMP Venous/Arterial Blood Management Protection System	Nov 28, 2016	Substantially Equivalent	Edwards Lifesciences, LLC
K160884	CXI Support Catheter	Nov 22, 2016	Substantially Equivalent	Cook Incorporated
K161921	SwiftNINJA Microcatheter	Nov 04, 2016	Substantially Equivalent	Merit Medical Systems, Inc.
K161402	Bullfrog Micro-Infusion Device	Aug 18, 2016	Substantially Equivalent	Mercator Medsystems, Inc.
K161801	CrossCath Support Catheter	Jul 29, 2016	Substantially Equivalent	Cook Incorporated
K153501	Bullfrog Micro-Infusion Device	Apr 15, 2016	Substantially Equivalent	Mercator Medsystems, Inc.
K152625	MMS Guide Catheter	Mar 09, 2016	Substantially Equivalent	Micro Medical Solutions, Inc.
K153502	ClariVein IC	Jan 06, 2016	Substantially Equivalent	Vascular Insights, LLC
K142259	Direxion Torqueable Microcatheter	Sep 10, 2014	Substantially Equivalent	Boston Scientific Corp
K140329	RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT	May 15, 2014	Substantially Equivalent	Boston Scientific
K140637	PEREGRINE SYSTEM INFUSION CATHETER	Mar 26, 2014	Substantially Equivalent	Ablative Solutions, Inc.
K131772	CANTATA(R) 2.9 MICROCATHETER	Feb 20, 2014	Substantially Equivalent	Cook, Inc.
K130569	ND NABIL DIB INFUSION CATHETER	Nov 15, 2013	Substantially Equivalent	Translational Research Institute
K132947	DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS	Oct 18, 2013	Substantially Equivalent	Boston Scientific Corp
K123477	VIA MICROCATHETER, VIA PLUS MICROCATHETER	Mar 19, 2013	Substantially Equivalent	Sequent Medical, Inc.
K122796	CXI SUPPORT CATHETER	Oct 11, 2012	Substantially Equivalent	Cook, Inc.
K113289	ORION MICRO CATHETER	Aug 01, 2012	Substantially Equivalent	Micro Therapeutics, Inc.
K113773	ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL	Jan 18, 2012	Substantially Equivalent	St Jude Medical
K111490	MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS	Sep 16, 2011	Substantially Equivalent	Ev3, Inc.
K111263	CXI TRIFORCE	Jul 25, 2011	Substantially Equivalent	Cook Incorporated
K101450	CANTATA MICROCATHETER	Dec 30, 2010	Substantially Equivalent	Cook, Inc.
K100892	RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX	Apr 12, 2010	Substantially Equivalent	Boston Scientific Corp
K093750	ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA	Dec 09, 2009	Substantially Equivalent	Ev3, Inc.
K093052	CROSSCATH SUPPORT CATHTER	Dec 08, 2009	Substantially Equivalent	Cook, Inc.
K091559	MARKSMANN CATHETER	Sep 18, 2009	Substantially Equivalent	Chestnut Medical Technologies, Inc.
K081147	ISOFLOW INFUSION CATHETER	May 29, 2009	Substantially Equivalent	Vascular Designs, Inc.
K090870	ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY	May 01, 2009	Substantially Equivalent	Micro Therapeutics, Inc.
K082613	MERIT MICROCATHETER	Dec 30, 2008	Substantially Equivalent	Merit Medical Systems, Inc.
K082163	FLOWMEDICA BENEPHIT INFUSION SYSTEMS	Oct 29, 2008	Substantially Equivalent	Flowmedica, Inc.
K082519	FINECROSS MG CORONARY MICRO-GUIDE CATHETER	Sep 26, 2008	Substantially Equivalent	Terumo Medical Corp.
K080737	MIRAFLEX HIGH FLOW MICROCATHETER	Aug 08, 2008	Substantially Equivalent	Cook, Inc.
K053310	VASCON ROAMER MICROCATHETER	Jul 03, 2008	Substantially Equivalent	Vascon, LLC
K073166	ENDOWAVE INFUSION SYSTEM	Apr 22, 2008	Unknown	Ekos Corp.
K071468	CLARIVEIN CATHETER	Mar 20, 2008	Substantially Equivalent	Vascular Insights, LLC
K073400	VARICATH PERIPHERAL INFUSION CATHETER	Dec 20, 2007	Substantially Equivalent	Veinrx, Inc.
K072724	CXI SUPPORT CATHETER	Nov 09, 2007	Substantially Equivalent	Cook, Inc.
K070979	PULL TAB SQUEEZE FLUSH	Sep 19, 2007	Substantially Equivalent	Icu Medical, Inc.
K070384	ARGON CONTINUOUS FLUSH DEVICE	Mar 29, 2007	Substantially Equivalent	Argon Medical Devices, Inc.
K070279	MODIFICATION TO HYPERTRANSIT INFUSION CATHETER	Mar 14, 2007	Substantially Equivalent	Cordis Neurovascular, Inc.
K062752	MERCATOR MICROSYRINGE II INFUSION CATHETER	Dec 07, 2006	Substantially Equivalent	Mercator Medsystems, Inc.
K060224	MODIFICATION TO MIRA-FLEX 18 MICROCATHETER	Mar 06, 2006	Substantially Equivalent	Cook Incorporated
K051990	ECHELON MICRO CATHETER	Jan 04, 2006	Substantially Equivalent	Micro Therapeutics, Inc.
K052841	MIRA-FLEX 18 MICROCATHETER	Dec 08, 2005	Substantially Equivalent	Cook, Inc.
K052738	INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044	Dec 06, 2005	Substantially Equivalent	Veinrx, Inc.
K043538	HYPERTRANSIT INFUSION CATHETER	Apr 18, 2005	Substantially Equivalent	Cordis Neurovascular, Inc.
K050630	PIVOT STEERABLE MICROCATHETER	Mar 22, 2005	Substantially Equivalent	Boston Scientific - Precision Vascular
K050205	BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH	Mar 04, 2005	Substantially Equivalent	Flowmedica, Inc.
K042187	ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90	Sep 02, 2004	Substantially Equivalent	Micro Therapeutics, Inc.
K033913	PROGREAT	Mar 11, 2004	Substantially Equivalent	Terumo Medical Corp.
K040139	ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER	Feb 18, 2004	Substantially Equivalent	Endobionics, Inc.
K034036	MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055	Feb 13, 2004	Substantially Equivalent	Micro Therapeutics, Inc.
K033726	PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER	Jan 16, 2004	Substantially Equivalent	Precision Vascular
K033569	FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH	Jan 13, 2004	Substantially Equivalent	Flowmedica, Inc.
K032494	PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER	Sep 05, 2003	Substantially Equivalent	Precision Vascular Systems, Inc.
K031992	ECHELON MICRO CATHETER, MODEL 105-5091	Aug 07, 2003	Substantially Equivalent	Micro Therapeutics, Inc.
K030688	ECHELON MICRO CATHETER, MODEL 105-5092-150	Mar 28, 2003	Substantially Equivalent	Micro Therapeutics, Inc.
K024122	NAUTICA MICRO CATHETER, MODEL 105-5094-153	Mar 07, 2003	Substantially Equivalent	Micro Therapeutics, Inc.
K023351	MAGIC INFUSION CATHETER	Feb 20, 2003	Substantially Equivalent	Advanced Interventional Technologies, LLC
K024118	ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066	Feb 03, 2003	Substantially Equivalent	Micro Therapeutics, Inc.
K021591	PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS	May 22, 2002	Substantially Equivalent	Cordis Neurovascular, Inc.
K020680	PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS	Mar 27, 2002	Substantially Equivalent	Cordis Neurovascular, Inc.
K020733	PVS 1500 SDS	Mar 21, 2002	Substantially Equivalent	Precision Vascular Systems, Inc.
K011646	NEUROEDGE INFUSION CATHETER	Aug 27, 2001	Substantially Equivalent	Neuro Vasx, Inc.
K010004	FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065	Feb 13, 2001	Substantially Equivalent	Micro Therapeutics, Inc.
K003925	PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS	Jan 08, 2001	Substantially Equivalent	Cordis Neurovascular, Inc.
K002723	REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA	Sep 28, 2000	Substantially Equivalent	Micro Therapeutics, Inc.
K994155	EXCELSIOR 1018 MICROCATHETER	Aug 03, 2000	Substantially Equivalent	Boston Scientific, Target
K001966	REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND	Jul 20, 2000	Substantially Equivalent	Micro Therapeutics, Inc.
K000177	RENEGADE HI-FLO MICROCATHETER	Apr 07, 2000	Substantially Equivalent	Boston Scientific Corp
K993672	REBAR MICRO CATHETER, MODELS 105-5080, 105-5086	Jan 04, 2000	Substantially Equivalent	Micro Therapeutics, Inc.
K993266	PROWLER PLUS INFUSION CATHETER	Oct 28, 1999	Substantially Equivalent	Cordis Neurovascular, Inc.
K983003	1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS	Sep 17, 1998	Substantially Equivalent	Cordis Neurovascular, Inc.
K974473	EASY RIDER MICRO CATHETER	Jun 17, 1998	Substantially Equivalent	Micro Therapeutics, Inc.
K980104	FLOW RIDER FLOW DIRECTED MICRO CATHETER	Apr 10, 1998	Substantially Equivalent	Micro Therapeutics, Inc.
K971619	MICROFUSE MEMBRANE INFUSION CATHETER	Feb 27, 1998	Substantially Equivalent	E-Med Corp.
K974222	CES MASSTRANSIT INFUSION CATHETER	Feb 10, 1998	Substantially Equivalent	Cordis Neurovascular, Inc.
K973645	RENEGADE FIBER BRAIDED MICROCATHETER	Nov 19, 1997	Substantially Equivalent	Boston Scientific Corp
K972518	TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER	Nov 04, 1997	Substantially Equivalent	Cordis Neurovascular, Inc.
K971306	FG INFUSION CATHETER	Jul 14, 1997	Substantially Equivalent	Cordis Neurovascular, Inc.
K964868	2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER	May 20, 1997	Substantially Equivalent	Micro Therapeutics, Inc.
K962129	CONTINUOUS FLUSH DEVICE	Apr 15, 1997	Substantially Equivalent	Merit Medical Systems, Inc.
K965189	SPINNAKER	Mar 24, 1997	Substantially Equivalent	Target Therapeutics
K965181	CES INFUSION CATHETER	Mar 21, 1997	Substantially Equivalent	Cordis Neurovascular, Inc.
K964154	SEGUE INFUSION CATHETER	Jan 14, 1997	Substantially Equivalent	Interventional Innovations Corp.
K963988	INTRAVASCULAR INFUSION DEVICE	Dec 12, 1996	Substantially Equivalent	Boston Scientific Corp
K961668	MICROFERRET CATHETER	Nov 04, 1996	Substantially Equivalent	Cook, Inc.
K955525	FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70	Aug 08, 1996	Substantially Equivalent	Interventional Innovations Corp.
K955534	SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)	Aug 01, 1996	Substantially Equivalent	International Innovations, Inc.
K961294	SCIMED DISPATCH GOLD CORONARY CATHETER	Jul 03, 1996	Substantially Equivalent	Scimed Life Systems, Inc.
K961527	MX703 AND MX730 CONTINUOUS FLUSH DEVICES	Jun 06, 1996	Substantially Equivalent	Medex, Inc.
K954457	MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER	May 15, 1996	Substantially Equivalent	Medi-Tech, Inc.
K953133	SCIMED DISPATCH CORONARY INFUSION CATHETER	Feb 23, 1996	Substantially Equivalent	Scimed Life Systems, Inc.
K954020	MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE	Jan 02, 1996	Substantially Equivalent	Micro Therapeutics, Inc.
K954949	TRANSIT INFUSION CATHETER WITH SIDEHOLES	Dec 22, 1995	Substantially Equivalent	Cordis Neurovascular, Inc.
K952874	TRANSIT INFUSION CATHETER	Aug 21, 1995	Substantially Equivalent	Cordis Neurovascular, Inc.
K952872	SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER	Jul 27, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K945666	EVOLUTION(TM) MICROCATHETER	Jun 21, 1995	Substantially Equivalent	Boston Scientific Corp
K951602	PULSE*SPRAY INFUSION SYSTEM	Jun 14, 1995	Substantially Equivalent	Angiodynamics, Div. E-Z-Em, Inc.
K945909	NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER	Jun 02, 1995	Substantially Equivalent	Navarre Biomedical , Ltd.
K945904	SCIMED(R) VENTURE(TM) II INFUSION CATHETER	May 19, 1995	Substantially Equivalent	Scimed Peripheral Interventions
K951502	CVD BULLET INFUSION CATYHETER	May 10, 1995	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K951503	CVD BULLETT HI-FLO INFUSION CATHETER	May 04, 1995	Substantially Equivalent	Cardiovascular Dynamics, Inc.
K945593	SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER	Jan 13, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K935349	LOCALMED INFUSION CATHETER	Oct 18, 1994	Substantially Equivalent	Localmed, Inc.
K931335	SCIMED(R) VENTURE(TM) INFUSION CATHETER	Jul 27, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K932800	CARDIMA TRACKER(R) INFUSION CATHETER	Dec 21, 1993	Substantially Equivalent	Cardima, Inc.
K932616	SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER	Dec 15, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K932188	SAFESET RESERVOIR	Oct 25, 1993	Substantially Equivalent	Abbott Laboratories
K921247	ZEPHYR INFUSION CATHETER	Jun 29, 1993	Substantially Equivalent	Target Therapeutics
K914751	SELECTIVE INFUSION II CATHETER	May 24, 1993	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K924661	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	Apr 08, 1993	Substantially Equivalent	Baxter Healthcare Corp
K923368	MAGIC INFUSION CATHETER	Apr 07, 1993	Substantially Equivalent	Target Therapeutics
K914979	EDM(R) INFUSION CATHETER	Sep 16, 1992	Substantially Equivalent	Peripheral Systems Group
K905447	E-Z-EM PULSED INFUSION SYSTEM	Apr 01, 1991	Substantially Equivalent	E-Z-Em, Inc.
K896819	VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION	Jan 19, 1990	Substantially Equivalent	Baxter Healthcare Corp
K885281	VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION	Mar 03, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884946	JEHLE CORONARY PERFUSION CATHETERS	Feb 06, 1989	Substantially Equivalent	Pilling Co.
K874242	JEHLE CORONARY PERFUSION CATHETERS	Dec 07, 1987	Substantially Equivalent	Pilling Co.
K860570	ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE	Mar 31, 1986	Substantially Equivalent	Parke-Davis Co.
K832058	ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.	Sep 12, 1983	Substantially Equivalent	Parke-Davis Co.
K831730	CONTINUOUS FLUSH DEVICE	Jul 18, 1983	Substantially Equivalent	American Pharmaseal Div. Ahsc
K831637	ACCU-FLUSH	Jun 30, 1983	Substantially Equivalent	Accu-Line
K812173	FLUSHFLO II	Aug 18, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K811410	MEDI-TRACE	Jun 12, 1981	Substantially Equivalent	Graphic Controls Corp.
K801829	MEDI-TRACE DISP. FLUSHING DEV./MONITOR	Aug 27, 1980	Substantially Equivalent	Graphic Controls Corp.
K801173	ANGIO-FLO MONITORING KIT	May 28, 1980	Substantially Equivalent	Hospital Products Co.
K791890	CONTINUOUS FLUSH DEVICE, CAT. #14-370	Dec 13, 1979	Substantially Equivalent	Norton Performance Plastics Corp.
K792141	CONTINUOUS FLUSH DEVICE	Dec 05, 1979	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K791844	CRITIFLO & CRITIFLO DOME	Oct 02, 1979	Substantially Equivalent	Gould, Inc.
K790455	MICROFLUSH	Mar 23, 1979	Substantially Equivalent	Medex, Inc.
K790327	ANGIO-FLO	Feb 26, 1979	Substantially Equivalent	Deseret Medical, Inc.
K780479	DELTA-FLOW	Nov 22, 1978	Substantially Equivalent	Tri-Delta Intl.
K770432	MICROFLUSH	Mar 16, 1977	Substantially Equivalent	Medex, Inc.
K761273	FLUSHFLO-MODEL CC1-6	Jan 12, 1977	Substantially Equivalent	Bentley Laboratories, Inc.