510(k) K152665 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
PolarCath Peripheral Dilatation System
| Applicant | Nucyro Vascular, LLC, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 26, 2015 |
| Received | Sep 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2019 | Nucryo Vascular Inc. The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is avai Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.