510(k) K220629 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Emerge Monorail PTCA Dilatation Catheter
| Applicant | Boston Scientific, Galway, IE |
| Decision | Substantially Equivalent, Mar 24, 2022 |
| Received | Mar 4, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220629
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.