510(k) K243704 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
| Applicant | Brosmed Medical Co., Ltd., Dongguan, CN |
| Decision | Substantially Equivalent, Feb 27, 2025 |
| Received | Nov 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243704
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.