K944290 is an FDA 510(k) clearance for the CATHETERS, BILIARY CATHETERS, UROLOGICAL. This device is classified as a Tube, Drainage, Suprapubic (Class II - Special Controls, product code FFA).
Submitted by Boston Scientific Corp (Spencer, US). The FDA issued a Cleared decision on December 8, 1994, 97 days after receiving the submission on September 2, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K944290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1994 |
| Decision Date | December 08, 1994 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFA — Tube, Drainage, Suprapubic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5090 |