510(k) K212026
K212026 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Amplatzer Steerable Delivery Sheath". The FDA issued a decision of Substantially Equivalent on Sep 27, 2021. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. ABBOTT MEDICAL has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 27, 2021
- Date Received
- Jun 29, 2021
- 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
- 510(k)