510(k) K230705 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
POT PTCA Balloon Dilatation Catheter
| Applicant | Brosmed Medical Co., Ltd., Dongguan, CN |
| Decision | Substantially Equivalent, Apr 11, 2023 |
| Received | Mar 14, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230705
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.