510(k) K200206
K200206 is an FDA 510(k) premarket notification submitted by Stryker Neurovascular for the device "AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter". The FDA issued a decision of Substantially Equivalent on February 27, 2020. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Stryker Neurovascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2020
- Date Received
- January 28, 2020
- Clearance Type
- Special
- 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
To provide vascular access to the neurovasculature for interventional or diagnostic procedures