MPB — Catheter, Hemodialysis, Non-Implanted Class II
FDA product code MPB covers "Catheter, Hemodialysis, Non-Implanted", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MPB
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250836 | medical components | 14F Duo-Flow® Side X Side Double Lumen Catheter | August 12, 2025 |
| K200426 | health line international corporation | Acute Dual Lumen Hemodialysis Catheter | December 24, 2020 |
| K192807 | medical components, inc. (dba medcomp) | Duo-Flow Side x Side Double Lumen Catheter | April 23, 2020 |
| K192302 | covidien | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurk | January 17, 2020 |
| K163458 | c.r. bard | Zenysis Short-Term Dialysis Catheter | April 4, 2017 |
| K161504 | cook incorporated | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | January 6, 2017 |
| K153190 | c.r. bard | Zenysis Short-Term Dialysis Catheter | January 5, 2016 |
| K122091 | cook | COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO H | July 29, 2013 |
| K120674 | covidien | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER | April 4, 2012 |
| K110793 | ameco medical industries | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI | December 16, 2011 |
| K102833 | foshan nanhai bai he medical technology co | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS | November 18, 2011 |
| K100451 | gambro renal products | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW | December 21, 2010 |
| K090102 | c.r. bard | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS | February 12, 2009 |
| K071145 | nipro medical corporation | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE | September 7, 2007 |
| K063355 | novosci | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW | July 27, 2007 |
| K070234 | jms north america | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS | May 22, 2007 |
| K040301 | gambro renal products | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A | November 1, 2004 |
| K030268 | c.r. bard | NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHET | July 30, 2003 |
| K030209 | kendall | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | May 13, 2003 |
| K022221 | deltec | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS | January 30, 2003 |