510(k) K250013
K250013 is an FDA 510(k) premarket notification submitted by Control Medical Technology, Inc. / Dba Ventiv Scientific for the device "VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)". The FDA issued a decision of Substantially Equivalent on March 24, 2025. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2025
- Date Received
- January 2, 2025
- 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.