FDA Product Code
FDA Product Code MPB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. | 2025-08-12 | Traditional | PDF ↗ |
| K200426 | Acute Dual Lumen Hemodialysis Catheter | Health Line International Corporation | 2020-12-24 | Traditional | PDF ↗ |
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2020-04-23 | Traditional | PDF ↗ |
| K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter | Covidien, LLC | 2020-01-17 | Traditional | PDF ↗ |
| K163458 | Zenysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2017-04-04 | Traditional | PDF ↗ |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | Cook Incorporated | 2017-01-06 | Special | PDF ↗ |
| K153190 | Zenysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2016-01-05 | Traditional | PDF ↗ |
| K122091 | COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY | Cook, Inc. | 2013-07-29 | Traditional | PDF ↗ |
| K120674 | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER | Covidien | 2012-04-04 | Special | PDF ↗ |
| K110793 | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS | Ameco Medical Industries | 2011-12-16 | Traditional | PDF ↗ |
| K102833 | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011-11-18 | Traditional | PDF ↗ |
| K100451 | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 | Gambro Renal Products, Inc. | 2010-12-21 | Traditional | PDF ↗ |
| K090102 | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS | C.R. Bard, Inc. | 2009-02-12 | Special | PDF ↗ |
| K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE | Nipro Medical Corporation | 2007-09-07 | Abbreviated | PDF ↗ |
| K063355 | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW | Novosci Corp. | 2007-07-27 | Traditional | PDF ↗ |
| K070234 | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS | Jms North America Corp. | 2007-05-22 | Special | PDF ↗ |
| K040301 | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A | Gambro Renal Products | 2004-11-01 | Traditional | PDF ↗ |
| K030268 | NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS | C.R. Bard, Inc. | 2003-07-30 | Abbreviated | PDF ↗ |
| K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | The Kendall Company | 2003-05-13 | Traditional | PDF ↗ |
| K022221 | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS | Deltec, Inc. | 2003-01-30 | Traditional | PDF ↗ |
| K010778 | NIAGARA SLIM-CATH | C.R. Bard, Inc. | 2001-04-13 | Special | PDF ↗ |
| K001958 | KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH | Keystone Medical | 2000-09-25 | Traditional | PDF ↗ |
| K993933 | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO | Arrow Intl., Inc. | 2000-09-14 | Traditional | PDF ↗ |
| K991320 | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN | Medical Components, Inc. | 1999-11-10 | Traditional | PDF ↗ |
| K980438 | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT | Medical Components, Inc. | 1999-06-10 | Traditional | PDF ↗ |
| K983511 | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH | Medical Components, Inc. | 1999-06-08 | Traditional | PDF ↗ |
| K991431 | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT | Arrow Intl., Inc. | 1999-05-26 | Special | PDF ↗ |
| K984022 | PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT | Arrow Intl., Inc. | 1999-05-18 | Traditional | PDF ↗ |
| K974236 | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB | Medical Components, Inc. | 1999-04-15 | Traditional | PDF ↗ |
| K965178 | NIAGARA DUAL LUMEN CATHETER | Vas-Cath, Inc. | 1997-08-19 | Traditional | PDF ↗ |
| K963446 | KENDALL DUAL LUMEN CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-03-18 | Traditional | PDF ↗ |
| K952660 | BRAUN HEMODIALYSIS CATHETER | B.Braun Medical, Inc. | 1996-09-17 | Traditional | PDF ↗ |
| K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER | Quinton, Inc. | 1996-09-13 | Traditional | PDF ↗ |
| K923691 | TWIN SILICONE CATHETER | Medical Components, Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K896252 | MODIFIED QUINTON SINGLE LUMEN CATHETER | Quinton, Inc. | 1990-01-29 | Traditional | PDF ↗ |
| K893188 | QUINTON SINGLE LUMEN CATHETER | Quinton, Inc. | 1989-06-08 | Traditional | PDF ↗ |
| K880583 | MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH | Quinton, Inc. | 1988-02-22 | Traditional | PDF ↗ |
| K871360 | 10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE | Quinton, Inc. | 1987-04-29 | Traditional | PDF ↗ |
Product code MPB · Class II · Gastroenterology, Urology. Data: openFDA.