510(k) K211989
K211989 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Aveir Introducer". The FDA issued a decision of Substantially Equivalent on Jul 27, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. ABBOTT MEDICAL has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 2021
- Date Received
- Jun 28, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)