510(k) K193495 ยท PNO Catheter, Percutaneous, Cutting/Scoring
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
| Applicant | Transit Scientific, Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 29, 2020 |
| Received | Dec 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193495
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.