K022644 is an FDA 510(k) clearance for the RETRO REPAIR KIT, MODEL PRRK5, 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 November 6, 2002, 90 days after receiving the submission on August 8, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K022644 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | August 08, 2002 |
| Decision Date | November 06, 2002 |
| Days to Decision | 90 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 |