K833572

Substantially Equivalent

HEPARIN-COATED BALLOON THERMODILUT

Applicant: Critikon Company, LLC
Product code: DYG
Advisory panel: Cardiovascular
Date received: 1983-10-12
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.