510(k) K062435
- Device
- REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
- Applicant
- SPIRE BIOMEDICAL, INC.
- 510(k) number
- K062435
- Product code
- NFK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-05
- Date received
- 2006-08-21
- Regulation
- 876.5540
- Classification name
- Kit, Repair, Catheter, Hemodialysis
- 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
- SHEKHAR NIMKAR
- Address
- One Patriots Park Bedford MA US 01730 01730
FDA Registration Numbers#
- 1722746
- 3006082230
- 9680794
- 9617592
- 3006260740
- 1319639
- 1018233
- 3015859709
- 2030624
- 3009211636
- 1061124
- 3030574705
- 9610849
- 1282497
- 3010041511
- 3003915875
- 2518902
Source Documents#
Other 510(k) Records For Product Code NFK #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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