510(k) K163259
K163259 is an FDA 510(k) premarket notification submitted by Stryker Neurovascular for the device "AXS Offset Delivery Assist Catheter". The FDA issued a decision of Substantially Equivalent on Jul 28, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Stryker Neurovascular has 32 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 2017
- Date Received
- Nov 21, 2016
- 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
- 510(k)