510(k) K252702 ยท DQO Catheter, Intravascular, Diagnostic
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-1
| Applicant | Bioptimal International Pte. , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, May 28, 2026 |
| Received | Aug 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252702
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.