510(k) K153742 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Apollo Balloon Dilatation Catheter
| Applicant | Brosmed Medical Co., Ltd., Dongguan, CN |
| Decision | Substantially Equivalent, Aug 8, 2016 |
| Received | Dec 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153742
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.