AIR-BAND RADIAL COMPRESSION DEVICE— 510(k) K122405

Substantially Equivalent

Datascope Corp., Cardiac Assist Division

FDA 510(k) clearance K122405 for AIR-BAND RADIAL COMPRESSION DEVICE, Substantially Equivalent on 2012-11-09. Applicant: Datascope Corp., Cardiac Assist Division.

Clearance details

Applicant: Datascope Corp., Cardiac Assist Division
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2012-08-07
Decision date: 2012-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, 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.