510(k) K201682
K201682 is an FDA 510(k) premarket notification submitted by Rist Neurovascular, Inc. for the device "RIST Radial Access Catheter". The FDA issued a decision of Substantially Equivalent on Sep 28, 2020. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Rist Neurovascular, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2020
- Date Received
- Jun 22, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- NE
- Submission Type
- 510(k)
To provide vascular access to the neurovasculature for interventional or diagnostic procedures