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 VentiV 7Fr-12Fr MP Mechanical Thrombectomy System is a single-use, sterile catheter device designed to remove fresh soft emboli and thrombi from peripheral blood vessels. The system comprises a mechanical aspirator and over-the-wire catheters ranging from 7Fr to 12Fr in diameter, used via percutaneous or surgical access to the patient's legs, arms, or chest.

The subject device matches the predicate in fundamental design: over-the-wire intravascular catheter with manual syringe aspiration (−760 mmHg vacuum), round aspiration lumen, 0.035" guidewire compatibility, integrated radiopaque markers, and ETO sterilization. Key differences include catheter sizes (7–12Fr vs. 7–11Fr predicate), usable lengths extended to 100 cm (vs. 60–90 cm), and tip shape changed from straight to multipurpose.

ISO 10993 biocompatibility compliance is cited. The document references FDA guidance on 510(k) submissions and Quality System regulations (21 CFR Part 820) but does not specify additional consensus standards such as ASTM or IEC for performance testing.

The device is substantially equivalent because it uses identical fundamental technology (manual aspiration-based thrombectomy via over-the-wire catheters), identical indications and patient anatomy, the same material properties and sterilization method, and equivalent operating principles. Non-clinical testing confirmed the subject device meets specifications, intended use, and performance claims with aged test units. The predicate (K200871) shares the same classification, single-use status, prescription-only designation, and aspirator clearance; the minor design changes (multipurpose vs. straight tip, extended sizes/lengths) do not alter the basic function or introduce new risks.