510(k) K213494
K213494 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Aveir Retrieval Catheter". The FDA issued a decision of Substantially Equivalent on April 1, 2022. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2022
- Date Received
- November 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Percutaneous Retrieval
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type