REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
FDA 510(k) clearance K062435 · decided 2006-12-05
Clearance details
- K-number
- K062435
- Device name
- REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
- Applicant
- Spire Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-21
- Decision date
- 2006-12-05
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- NFK
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K101261) | C.R. Bard, Inc. | 2010-07-29 |
| ACUTE AND CHRONIC CATHETER REPAIR KIT (K092797) | Kendall | 2009-11-19 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K063446) | C.R. Bard, Inc. | 2006-12-15 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K030442) | C.R. Bard, Inc. | 2003-07-21 |
| RETRO REPAIR KIT, MODEL PRRK5 (K022644) | Spire Biomedical, Inc. | 2002-11-06 |
| MEDCOMP REPAIR KIT, MODEL ASPCRPK (K022570) | Medcomp | 2002-10-31 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K022561) | C.R. Bard, Inc. | 2002-08-23 |
| DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (K020430) | Diatek, Inc. | 2002-05-09 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K011015) | C.R. Bard, Inc. | 2001-06-22 |
| MEDCOMP ASH SPLIT (K011576) | Medical Components, Inc. | 2001-06-21 |
Recalls involving this device
No recalls on record reference this clearance.