510(k) K250706 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Ang
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Apr 4, 2025 |
| Received | Mar 10, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250706
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.