510(k) K213771
K213771 is an FDA 510(k) premarket notification submitted by Mivi Neurovascular, Inc. for the device "Merlin Aspiration System". The FDA issued a decision of Substantially Equivalent on January 27, 2022. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Mivi Neurovascular, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2022
- Date Received
- December 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Embolectomy
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type