K963446 is an FDA 510(k) clearance for the KENDALL DUAL LUMEN CATHETER, a Catheter, Hemodialysis, Non-implanted (Class II — Special Controls, product code MPB), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on March 18, 1997, 196 days after receiving the submission on September 3, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K963446 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 1996 |
| Decision Date | March 18, 1997 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MPB — Catheter, Hemodialysis, Non-implanted |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |