510(k) K202187 ยท PNO Catheter, Percutaneous, Cutting/Scoring
FLEX Vessel Prep System
| Applicant | Venturemed Group, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 11, 2020 |
| Received | Aug 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202187
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.