510(k) K252513 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
| Applicant | Poly Medicure Limited, Faridabad, IN |
| Decision | Substantially Equivalent, Apr 1, 2026 |
| Received | Aug 11, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252513
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.