K210419 is an FDA 510(k) clearance for the BIOTEQ Drainage Catheter BT-PDS-series. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Bioteque Corporation (Taipei, TW). The FDA issued a Cleared decision on April 13, 2022, 426 days after receiving the submission on February 11, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K210419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2021 |
| Decision Date | April 13, 2022 |
| Days to Decision | 426 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 |