510(k) K192122
K192122 is an FDA 510(k) premarket notification submitted by Stryker for the device "Trevo Trak 21 Microcatheter". The FDA issued a decision of Substantially Equivalent on Nov 22, 2019. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Stryker has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 22, 2019
- Date Received
- Aug 6, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)