Product code NFK
- Device name
- Kit, Repair, Catheter, Hemodialysis
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Hemodialysis Tray
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101261 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | C.R. Bard, Inc. | 2010-07-29 |
| K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | Kendall | 2009-11-19 |
| K063446 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | C.R. Bard, Inc. | 2006-12-15 |
| K062435 | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS | Spire Biomedical, Inc. | 2006-12-05 |
| K030442 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | C.R. Bard, Inc. | 2003-07-21 |
| K022644 | RETRO REPAIR KIT, MODEL PRRK5 | Spire Biomedical, Inc. | 2002-11-06 |
| K022570 | MEDCOMP REPAIR KIT, MODEL ASPCRPK | Medcomp | 2002-10-31 |
| K022561 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | C.R. Bard, Inc. | 2002-08-23 |
| K020430 | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) | Diatek, Inc. | 2002-05-09 |
| K011015 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | C.R. Bard, Inc. | 2001-06-22 |
| K011576 | MEDCOMP ASH SPLIT | Medical Components, Inc. | 2001-06-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20801902197379 | ARROW | TELEFLEX INCORPORATED | 2022-12-08 |
| 20801902197355 | ARROW | TELEFLEX INCORPORATED | 2022-12-02 |
| 20801902197409 | ARROW | TELEFLEX INCORPORATED | 2022-12-01 |
| 20801902197461 | ARROW | TELEFLEX INCORPORATED | 2022-12-01 |
| 20801902197485 | ARROW | TELEFLEX INCORPORATED | 2022-12-01 |
| 20801902195337 | ARROW | TELEFLEX INCORPORATED | 2022-11-15 |
| 20801902196723 | ARROW | TELEFLEX INCORPORATED | 2022-11-15 |
| 20801902195238 | ARROW | TELEFLEX INCORPORATED | 2022-11-11 |
| 20801902197423 | ARROW | TELEFLEX INCORPORATED | 2022-11-09 |
| 00884908158205 | CATHETER REPAIR KIT | Medical Components, Inc. | 2020-11-26 |
| 00884908146042 | N/A | Medical Components, Inc. | 2019-09-05 |
| 00801741045080 | Catheter Repair Kit | Bard Access Systems, Inc. | 2017-05-29 |
| 00801741045103 | Catheter Repair Kit | Bard Access Systems, Inc. | 2015-12-04 |
| 00801741045110 | RetrO Catheter Repair Kit | Bard Access Systems, Inc. | 2015-12-04 |
| 00884908039856 | REPAIR KIT | Medical Components, Inc. | 2015-10-23 |
| 00801902096135 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096821 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096814 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096807 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096791 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096159 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096142 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096128 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902096111 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902033406 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902031594 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902031587 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902031570 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801902031563 | ARROW | TELEFLEX INCORPORATED | 2015-10-16 |
| H787103018010 | DuraFlow | ANGIODYNAMICS, INC. | 2015-09-15 |