APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)— 510(k) K760151

Substantially Equivalent

Edwards Laboratories

FDA 510(k) clearance K760151 for APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN), Substantially Equivalent on 1976-08-26. Applicant: Edwards Laboratories.

Clearance details

Applicant: Edwards Laboratories
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1976-07-01
Decision date: 1976-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.