510(k) K192135
K192135 is an FDA 510(k) premarket notification submitted by MicroVention, Inc. for the device "VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)". The FDA issued a decision of Substantially Equivalent on December 24, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. MicroVention, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 2019
- Date Received
- August 7, 2019
- 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