510(k) K214106
K214106 is an FDA 510(k) premarket notification submitted by Traverse Vascular, Inc. for the device "QuikPass Catheter". The FDA issued a decision of Substantially Equivalent on Jan 28, 2022. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 28, 2022
- Date Received
- Dec 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)