#557 DISPOSABLE CARDIOVASCULAR CLAMP— 510(k) K881448

Substantially Equivalent

Alpha Industries, Inc.

FDA 510(k) clearance K881448 for #557 DISPOSABLE CARDIOVASCULAR CLAMP, Substantially Equivalent on 1988-06-30. Applicant: Alpha Industries, Inc..

Clearance details

Applicant: Alpha Industries, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1988-04-06
Decision date: 1988-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.