K911630 is an FDA 510(k) clearance for the LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 27, 1991, 169 days after receiving the submission on April 11, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K911630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1991 |
| Decision Date | September 27, 1991 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |