Product Code: MSD FDA class 2 21 CFR 876.5540

Catheter, Hemodialysis, Implanted

Gastroenterology, Urology

An Implanted Hemodialysis Catheter is a surgically placed vascular access device used to provide long-term access to the bloodstream for patients undergoing hemodialysis, typically for those with end-stage renal disease. This device is both an implant and classified as life-sustaining, reflecting its critical role in supporting patients dependent on dialysis. It is FDA Class 2, requiring 510(k) clearance, and carries product code MSD under 21 CFR 876.5540 in the Gastroenterology and Urology specialty.

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510(k)s

124

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MSD
Device Class: FDA class 2
Regulation Number: 876.5540
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 124 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241581	Hemodialysis Catheter	May 16, 2025	Unknown	Haolang Medical USA Corporation
K210461	End Cap	Sep 14, 2021	Substantially Equivalent	Medical Components Inc (Medcomp)
K203575	GlidePath Retro Long-Term Hemodialysis Catheter	Jul 01, 2021	Unknown	C.R. Bard, Inc.
K211410	GlidePath 13F Long-Term Hemodialysis Catheter	Jun 04, 2021	Unknown	Bard Peripheral Vascular, Inc.
K203767	Pristine Long-Term Hemodialysis Catheter	Apr 02, 2021	Unknown	C B Bard, Inc.
K202150	GlidePath 7.5F Long-Term Dialysis Catheter	Nov 18, 2020	Unknown	C.R. Bard, Inc.
K202176	Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes	Sep 03, 2020	Substantially Equivalent	Medical Components, Inc. (dba MedComp)
K200627	GlidePath 10F Long-Term Dialysis Catheter	Jun 22, 2020	Unknown	C.R. Bard, Inc.
K190527	GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters	Mar 05, 2020	Unknown	C. R. Bard
K182443	Pristine Hemodialysis Catheter	May 31, 2019	Substantially Equivalent	Pristine Access Technologies , Ltd.
K173667	15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes	May 17, 2018	Unknown	Medical Components, Inc. (dba MedComp)
K173805	NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)	Feb 08, 2018	Unknown	Marvao Medical Devices, Ltd.
K171571	NexSite HD, Hemodialysis Step Tip Catheter (60cm)	Nov 30, 2017	Unknown	Marvao Medical Devices, Ltd.
K171618	Symetrex Long Term Hemodialysis Catheter	Nov 16, 2017	Unknown	Medcomp (Dba Medical Components, Inc.)
K161026	NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)	Aug 09, 2016	Unknown	Marvao Medical Devices, Ltd.
K151967	Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter	Apr 04, 2016	Unknown	Merit Medical Systems, Inc.
K143567	NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)	Mar 31, 2015	Unknown	Marvao Medical Devices, Ltd.
K140884	SYMETREX LONG TERM HEMODIALYSIS CATHETER	Nov 26, 2014	Unknown	Phase One Medical
K140492	NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE	Nov 13, 2014	Substantially Equivalent	Marvao Medical Devices, Ltd.
K141051	VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU	Jul 07, 2014	Substantially Equivalent	Arrow International, Inc.
K141363	CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER	Jun 18, 2014	Unknown	Merit Medical Systems, Inc.
K130889	SPLIT CATH RG	Apr 28, 2014	Unknown	Medcomp
K131260	NMI DIALYSIS CATHETER	Feb 14, 2014	Unknown	Navilyst Medical, Inc.
K133796	NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),	Jan 31, 2014	Unknown	Marvao Medical Devices, Ltd.
K130851	CASCADE HEMODIALYSIS/APHERESIS CATHETER	Jan 09, 2014	Unknown	Health Line International Corporation
K131814	AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER	Jul 26, 2013	Unknown	Ameco Medical Industries
K130192	NEXTSTEP RETROGRADE	May 10, 2013	Unknown	Arrow International, Inc.
K123943	AMECATH DUAL LUMEN HEMODIALYSIS CATHETER	Apr 02, 2013	Substantially Equivalent	Ameco Medical Industries
K121933	NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)	Mar 14, 2013	Substantially Equivalent	Marvao Medical Devices, Ltd.
K123196	PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH	Jan 31, 2013	Substantially Equivalent	Covidien
K121848	SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM	Sep 21, 2012	Unknown	Medical Components, Inc.
K113487	HEMO-CATH 10F, HEMO-CATH 12.5F	Mar 09, 2012	Unknown	Medical Components, Inc.
K111651	SPLIT CATH III	Dec 08, 2011	Unknown	Medical Components, Inc.
K111817	PALINDROME RT CHRONIC CATHETER	Aug 30, 2011	Unknown	Covidien
K111900	NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER	Aug 17, 2011	Unknown	Teleflexmedical, Inc.
K111372	TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...	Aug 04, 2011	Unknown	Covidien
K111117	CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...	Jun 30, 2011	Unknown	Teleflexmedical, Inc.
K110936	DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT	Jun 10, 2011	Unknown	AngioDynamics, Inc.
K102238	ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER	Feb 01, 2011	Substantially Equivalent	Teleflexmedical, Inc.
K102043	ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER	Nov 18, 2010	Substantially Equivalent	Rex Medical
K101843	DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT	Oct 20, 2010	Unknown	AngioDynamics, Inc.
K100169	DURASPAN HEMODIALYSIS LONG-TERM CATHETER	Feb 18, 2010	Unknown	R4 Vascular, Inc.
K091506	DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520	Jan 08, 2010	Unknown	R4 Vascular, Inc.
K092597	CENTROS CHRONIC HEMODIALYSIS CATHETER SET	Nov 12, 2009	Unknown	Ash Access Technology, Inc.
K092205	PALINDROME P HEMODIALYSIS CATHETER	Oct 30, 2009	Unknown	Covidien Lp, Formerly Registered AS Kendall
K091760	DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)	Jul 20, 2009	Substantially Equivalent	Dermaport, Inc.
K090528	DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT	May 28, 2009	Unknown	C.R. Bard, Inc.
K090148	PROGUIDE CHRONIC DIALYSIS CATHETER	Apr 13, 2009	Substantially Equivalent	Merit Medical Systems, Inc.
K090101	EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS	Feb 10, 2009	Unknown	C.R. Bard, Inc.
K080400	ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT	May 13, 2008	Substantially Equivalent	AngioDynamics, Inc.
K073092	DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,	Jan 29, 2008	Substantially Equivalent	Spire Biomedical, Inc.
K073093	DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,	Jan 22, 2008	Substantially Equivalent	Spire Biomedical, Inc.
K071202	DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)	Nov 30, 2007	Unknown	Dermaport, Inc.
K072499	NOVOFLO CATHETER LT	Oct 30, 2007	Unknown	Novosci, Inc.
K071422	15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET	Aug 22, 2007	Unknown	Rex Medical
K070572	ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM	Jun 26, 2007	Unknown	Ash Access Technology, Inc.
K063441	15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55	Feb 12, 2007	Substantially Equivalent	Spire Biomedical, Inc.
K062901	HEMOCATH II	Feb 08, 2007	Substantially Equivalent	Med-Conduit, Inc.
K063431	15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40	Jan 29, 2007	Substantially Equivalent	Spire Biomedical, Inc.
K062671	14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)	Nov 03, 2006	Unknown	Kendall
K060288	RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS	Sep 01, 2006	Unknown	Spire Biomedical, Inc.
K060972	KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)	Aug 04, 2006	Substantially Equivalent	Kendall
K060155	15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS	May 09, 2006	Substantially Equivalent	Spire Biomedical, Inc.
K053589	LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING	Apr 13, 2006	Substantially Equivalent	Bard Access Systems, Inc.
K051280	MEDCOMP SPLIT CATH II	Nov 30, 2005	Substantially Equivalent	Medcomp
K051584	14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY	Oct 06, 2005	Substantially Equivalent	Kendall
K051748	HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS	Aug 12, 2005	Substantially Equivalent	C.R. Bard, Inc.
K042672	14F DUAL FLOATING DIALYSIS CATHETER/TRAY	Mar 23, 2005	Substantially Equivalent	Cardio Med Supplies, Inc.
K043292	HEMOCATH	Mar 16, 2005	Substantially Equivalent	Med-Conduit, Inc.
K040318	MEDCOMP SPLIT-CATH II	Feb 03, 2005	Substantially Equivalent	Medcomp
K043272	PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP	Dec 22, 2004	Substantially Equivalent	Kendall
K042858	55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS	Dec 03, 2004	Substantially Equivalent	Spire Biomedical, Inc.
K040328	15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER	Nov 24, 2004	Substantially Equivalent	Medcomp
K041914	PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER	Sep 27, 2004	Substantially Equivalent	Kendall
K042016	DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER	Sep 23, 2004	Substantially Equivalent	Datascope Corp.
K041559	55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55	Jul 30, 2004	Unknown	Spire Biomedical, Inc.
K040992	15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706	Jul 29, 2004	Unknown	Medcomp
K041006	TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR	May 19, 2004	Substantially Equivalent	Kendall
K040736	VAXCEL PLUS CHRONIC DIALYSIS CATHETER	May 18, 2004	Substantially Equivalent	Boston Scientific Corp
K040666	STEP-TIP CHRONIC HEMODIALYSIS CATHETER	May 14, 2004	Substantially Equivalent	Arrow International, Inc.
K040509	ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40	Apr 19, 2004	Substantially Equivalent	Spire Biomedical, Inc.
K040402	ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT	Apr 19, 2004	Substantially Equivalent	AngioDynamics, Inc.
K040492	VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER	Mar 16, 2004	Substantially Equivalent	Boston Scientific Corp
K040260	INTEGRAL HEMODIALYSIS CATHETER	Mar 05, 2004	Substantially Equivalent	Arrow Int'L.
K033676	PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER	Feb 20, 2004	Substantially Equivalent	Kendall
K040078	CANNON II PLUS	Feb 13, 2004	Unknown	Arrow International, Inc.
K032061	DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH	Dec 23, 2003	Unknown	Spire Biomedical, Inc.
K023023	LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA	Dec 04, 2003	Substantially Equivalent	Vasca, Inc.
K033294	HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER	Nov 26, 2003	Unknown	C.R. Bard, Inc.
K032712	VAXCEL PLUS CHRONIC DIALYSIS CATHETER	Oct 02, 2003	Substantially Equivalent	Boston Scientific Corp
K030277	SOFT-CELL DUAL LUMEN CATHETERS	Aug 06, 2003	Substantially Equivalent	C.R. Bard, Inc.
K030020	HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER	Jun 16, 2003	Substantially Equivalent	C.R. Bard, Inc.
K030502	14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55	May 20, 2003	Substantially Equivalent	Medcomp
K022662	DIATEK CANNON-CATHETER, MODEL CC5500	May 09, 2003	Unknown	Arrow Intl., Inc.
K023847	HEMO-STREAM HEMODIALYSIS CATHETER SET	Apr 30, 2003	Unknown	Rex Medical
K030983	TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY	Apr 25, 2003	Unknown	Deltec, Inc.
K022678	MEDCOMP SC4	Feb 24, 2003	Unknown	Medcomp
K022905	LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER	Dec 13, 2002	Substantially Equivalent	Horizon Medical Products, Inc.
K020936	10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL	Oct 11, 2002	Unknown	Medcomp
K021759	14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55	Aug 27, 2002	Unknown	Medcomp
K022000	POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)	Jul 19, 2002	Substantially Equivalent	Spire Biomedical, Inc.
K020315	14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL	May 24, 2002	Unknown	Medcomp
K020465	MEDCOMP ASH SPLIT-CATH II	May 22, 2002	Substantially Equivalent	Medcomp
K021212	24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS	May 17, 2002	Substantially Equivalent	Spire Biomedical, Inc.
K013160	POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER	Apr 11, 2002	Substantially Equivalent	Spire Biomedical, Inc.
K012562	MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER	Feb 08, 2002	Substantially Equivalent	Medical Components, Inc.
K011916	SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES	Oct 31, 2001	Substantially Equivalent	Horizon Medical Products, Inc.
K994105	HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40	Oct 03, 2001	Substantially Equivalent	Medical Components, Inc.
K012948	MODIFICATION TO VAXCEL DIALYSIS CATHETER	Oct 03, 2001	Substantially Equivalent	Boston Scientific/Medi-Tech
K010306	MEDCOMP EXCELL SPLIT TIP CATHETER	Oct 03, 2001	Substantially Equivalent	Medcomp
K012365	VAXCEL DIALYSIS CATHETER	Aug 24, 2001	Substantially Equivalent	Boston Scientific Corp
K010399	DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)	Aug 14, 2001	Substantially Equivalent	Diatek, Inc.
K003207	MEDCOMP ULTRA-FLOW CATHETER	Jun 12, 2001	Substantially Equivalent	Medical Components, Inc.
K002902	TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS	Apr 09, 2001	Substantially Equivalent	The Kendall Company
K010567	OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR	Mar 28, 2001	Substantially Equivalent	C.R. Bard, Inc.
K002901	KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER	Mar 28, 2001	Substantially Equivalent	The Kendall Company
K001633	LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000	Aug 24, 2000	Substantially Equivalent	Vasca, Inc.
K982326	MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY	Jul 12, 1999	Substantially Equivalent	Boston Scientific Corp
K981125	MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6	Feb 26, 1999	Substantially Equivalent	Medical Components, Inc.
K982333	MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY	Feb 12, 1999	Substantially Equivalent	Cook, Inc.
K981365	MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS	Nov 25, 1998	Substantially Equivalent	Sherwood Medical Co.
K981994	VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER	Sep 03, 1998	Substantially Equivalent	C.R. Bard, Inc.
K972207	MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM	Feb 23, 1998	Substantially Equivalent	Medcomp
K971925	MEDCOMP BIO-FLEX CS CATHETER (CS100)	Feb 23, 1998	Substantially Equivalent	Medical Components, Inc.