510(k) K221986 ยท PNO Catheter, Percutaneous, Cutting/Scoring
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
| Applicant | Transit Scientific, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 18, 2022 |
| Received | Jul 6, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221986
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.