510(k) K123473 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
HOPER PTCA BALLOON CATHETER
| Applicant | Lepu Medical Technology (Beijing) Co., Ltd., South Euclid OH, US |
| Decision | Substantially Equivalent, Aug 13, 2013 |
| Received | Nov 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123473
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.