ACUITY UNIVERSAL CUTTER— 510(k) K080154

Substantially Equivalent

Cardiac Pacemakers, Inc.

FDA 510(k) clearance K080154 for ACUITY UNIVERSAL CUTTER, Substantially Equivalent on 2008-03-20. Applicant: Cardiac Pacemakers, Inc..

Clearance details

Applicant: Cardiac Pacemakers, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2008-01-23
Decision date: 2008-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.