K250013

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)

510(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 UT · US
Product code: QEZ — Aspiration Thrombectomy Catheter
Decision date: 2025-03-24
Date received: 2025-01-02
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K250013.pdf

Official FDA record: K250013

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.