510(k) K213166
K213166 is an FDA 510(k) premarket notification submitted by Kaneka Medical America, LLC for the device "Thrombuster II Aspiration Catheter". The FDA issued a decision of Substantially Equivalent on October 26, 2021. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. Kaneka Medical America, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2021
- Date Received
- September 28, 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.