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124 FDA 510(k) clearances · Product code

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RecordFirmDate
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) (K022000)Spire Biomedical, Inc.2002-07-19
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL (K020315)Medcomp2002-05-24
MEDCOMP ASH SPLIT-CATH II (K020465)Medcomp2002-05-22
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K021212)Spire Biomedical, Inc.2002-05-17
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER (K013160)Spire Biomedical, Inc.2002-04-11
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER (K012562)Medical Components, Inc.2002-02-08
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES (K011916)Horizon Medical Products, Inc.2001-10-31
MEDCOMP EXCELL SPLIT TIP CATHETER (K010306)Medcomp2001-10-03
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 (K994105)Medical Components, Inc.2001-10-03
MODIFICATION TO VAXCEL DIALYSIS CATHETER (K012948)Boston Scientific/Medi-Tech2001-10-03
VAXCEL DIALYSIS CATHETER (K012365)Boston Scientific Corp2001-08-24
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) (K010399)Diatek, Inc.2001-08-14
MEDCOMP ULTRA-FLOW CATHETER (K003207)Medical Components, Inc.2001-06-12
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS (K002902)The Kendall Company2001-04-09
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR (K010567)C.R. Bard, Inc.2001-03-28
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER (K002901)The Kendall Company2001-03-28
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 (K001633)Vasca, Inc.2000-08-24
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY (K982326)Boston Scientific Corp1999-07-12
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 (K981125)Medical Components, Inc.1999-02-26
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY (K982333)Cook, Inc.1999-02-12
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (K981365)Sherwood Medical Co.1998-11-25
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER (K981994)C.R. Bard, Inc.1998-09-03
MEDCOMP BIO-FLEX CS CATHETER (CS100) (K971925)Medical Components, Inc.1998-02-23
MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM (K972207)Medcomp1998-02-23
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