510(k) K222538 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
| Applicant | Sino Medical Sciences Technology, Inc., Tianjin, CN |
| Decision | Substantially Equivalent, Dec 21, 2022 |
| Received | Aug 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222538
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.