K910917 is an FDA 510(k) clearance for the CATHLAB SILICONE BILIARY BALLOON CATHETER. This device is classified as a Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (Class II - Special Controls, product code GCA).
Submitted by Cathlab Corp. (Irvine, US). The FDA issued a Cleared decision on August 2, 1991, 150 days after receiving the submission on March 5, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K910917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1991 |
| Decision Date | August 02, 1991 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | GCA — Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |