Fluent inflation device— 510(k) K162272

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K162272 for Fluent inflation device, Substantially Equivalent on 2016-10-20. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 2016-08-12
Decision date: 2016-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.