510(k) K212211
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter by
Vascular Solutions, LLC
— Product Code DQY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2022
- Date Received
- July 15, 2021
- Clearance Type
- Traditional
- 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