510(k) K201246 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
| Applicant | Qualimed USA, LLC, Charlotte NC, US |
| Decision | Substantially Equivalent, Aug 3, 2021 |
| Received | May 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201246
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.