510(k) K212588
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter by
C.R. Bard, Inc.
— Product Code DQY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2022
- Date Received
- August 16, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type