VASOBand Vascular Compression Device— 510(k) K203803

Substantially Equivalent

Vasoinnovations, Inc.

FDA 510(k) clearance K203803 for VASOBand Vascular Compression Device, Substantially Equivalent on 2021-01-26. Applicant: Vasoinnovations, Inc..

Clearance details

Applicant: Vasoinnovations, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2020-12-28
Decision date: 2021-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Pasadena, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.