510(k) K243184 ยท DQY Catheter, Percutaneous
SAT CenterFlow Molding Balloon Catheter (IN20-00313)
| Applicant | Strait Access Technologies Holdings, Cape Town, ZA |
| Decision | Substantially Equivalent, Jun 25, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243184
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.