CARDIAC CATHETERIZATION PACK— 510(k) K840671

Substantially Equivalent

Professional Medical Services

FDA 510(k) clearance K840671 for CARDIAC CATHETERIZATION PACK, Substantially Equivalent on 1984-03-12. Applicant: Professional Medical Services.

Clearance details

Applicant: Professional Medical Services
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 1984-02-21
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.