K062435 is an FDA 510(k) clearance for the REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS. This device is classified as a Kit, Repair, Catheter, Hemodialysis (Class II - Special Controls, product code NFK).
Submitted by Spire Biomedical, Inc. (Bedford, US). The FDA issued a Cleared decision on December 5, 2006, 106 days after receiving the submission on August 21, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540. Hemodialysis Tray.
| 510(k) Number | K062435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2006 |
| Decision Date | December 05, 2006 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NFK — Kit, Repair, Catheter, Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Hemodialysis Tray |