K964899 is an FDA 510(k) clearance for the KENDALL CURITY URETERAL CATHETER, a Catheter, Ureteral, Gastro-urology (Class II — Special Controls, product code EYB), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on February 7, 1997, 66 days after receiving the submission on December 3, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K964899 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 1996 |
| Decision Date | February 07, 1997 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYB — Catheter, Ureteral, Gastro-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |