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)
FDA 510(k) clearance K250013 · decided 2025-03-24
Clearance details
- K-number
- K250013
- Device name
- 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)
- Applicant
- Control Medical Technology, Inc. / Dba Ventiv Scientific
- Decision
- Substantially Equivalent
- Date received
- 2025-01-02
- Decision date
- 2025-03-24
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Control Medical Technology
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Powered Aventus Thrombectomy System™ (K261105) | Inquis Medical | 2026-07-27 |
| Aventus Thrombectomy System (K262030) | Inquis Medical | 2026-07-15 |
| Liberant™ RX Aspiration Catheter (K253589) | Medtronic Interventional Vascular, Inc. | 2026-04-23 |
| FLOWRUNNER Aspiration System (K254208) | Expanse Medical, Inc. | 2026-03-20 |
| Aventus Thrombectomy System (K253925) | Inquis Medical | 2026-01-15 |
| AlphaVac Multipurpose Mechanical Aspiration System F1885 (K252509) | AngioDynamics, Inc. | 2025-11-24 |
| Vesalio Peripheral System (K251312) | Vesalio, Inc. | 2025-10-24 |
| FLOWRUNNER Aspiration System (K251488) | Expanse Medical, Inc. | 2025-07-14 |
| JETi Hydrodynamic Thrombectomy System (K243549) | ABBOTT MEDICAL | 2025-04-04 |
| AlphaVac MMA F1885 System (H787253020) (K240397) | AngioDynamics, Inc. | 2024-04-01 |
| JETi™Hydrodynamic Thrombectomy System (K232458) | ABBOTT MEDICAL | 2023-12-19 |
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (K213388) | AngioDynamics, Inc. | 2022-04-04 |
Recalls involving this device
No recalls on record reference this clearance.