K222663 is an FDA 510(k) clearance for the MultiStage Balloon Dilatation Catheter. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Dongguan TT Medical, Inc. (Dongguan, CN). The FDA issued a Cleared decision on March 9, 2023, 188 days after receiving the submission on September 2, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K222663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2022 |
| Decision Date | March 09, 2023 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |