510(k) K212199
K212199 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "ASAP Aspiration Catheter, ASAPLP Aspiration Catheter". The FDA issued a decision of Substantially Equivalent on November 3, 2021. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2021
- Date Received
- July 14, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aspiration Thrombectomy Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.