K250706
- 510(k) number
- K250706
- Device name
- 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 Angioplasty (PTCA) Catheter
- Applicant
- Biotronik, Inc. OR · US
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2025-04-04
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K250706.pdf
Official FDA record: K250706
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.