510(k) K251019 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
| Applicant | Bioteque Corporation, Taipei, TW |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Apr 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251019
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.