Passeo-35 Xeo Peripheral Dilatation Catheter +5 more— 510(k) K250706
Substantially EquivalentBiotronik, Inc.
FDA 510(k) clearance K250706 for Passeo-35 Xeo Peripheral Dilatation Catheter +5 more, Substantially Equivalent on 2025-04-04. Applicant: Biotronik, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lake Oswego, OR, US
Recent devices under product code LIT
view allMore clearances from Biotronik, Inc.
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.