510(k) K192302
- Device
- Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- Applicant
- Covidien, Llc
- 510(k) number
- K192302
- Product code
- MPB
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 2020-01-17
- Date received
- 2019-08-23
- Regulation
- 876.5540
- Classification name
- Catheter, Hemodialysis, Non-implanted
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carol S Ming
- Address
- 15 Hampshire St. Mansfield MA US 02048 02048
FDA Registration Numbers#
- 3010131137
- 9680794
- 1000563940
- 1061124
- 3006621386
- 3004784537
- 2527072
- 3003661577
- 9610849
- 3035111606
- 3000247873
- 1721676
- 3009888344
- 3006425876
- 3011137372
- 8041145
- 3007836437
- 1056186
- 1018233
- 3015859709
- 3012050423
- 3010041511
- 1820334
- 3009211636
- 3014656749
- 3030574705
- 2030624
- 3004134316
- 9617592
- 3010882065
- 3003915875
- 2518902
- 1722746
- 3007137787
- 2011171
- 1282497
- 3007544634
- 3006260740
- 3006082230
- 1319639
Source Documents#
Other 510(k) Records For Product Code MPB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. | 2025-08-12 |
| K200426 | Acute Dual Lumen Hemodialysis Catheter | Health Line International Corporation | 2020-12-24 |
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2020-04-23 |
| K163458 | Zenysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2017-04-04 |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | Cook Incorporated | 2017-01-06 |
| K153190 | Zenysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2016-01-05 |
| 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 |
| K120674 | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER | Covidien | 2012-04-04 |
| K110793 | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS | Ameco Medical Industries | 2011-12-16 |
| K102833 | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011-11-18 |
| 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 |
| K090102 | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS | C.R. Bard, Inc. | 2009-02-12 |
| K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE | Nipro Medical Corporation | 2007-09-07 |
| K063355 | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW | Novosci Corp. | 2007-07-27 |
| K070234 | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS | Jms North America Corp. | 2007-05-22 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases