K964514 is an FDA 510(k) clearance for the CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS, a Catheter, Peritoneal Dialysis, Single Use (Class II — Special Controls, product code FKO), submitted by Corpak, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 26, 1998, 605 days after receiving the submission on October 29, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K964514 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1996 |
| Decision Date | June 26, 1998 |
| Days to Decision | 605 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FKO — Catheter, Peritoneal Dialysis, Single Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |