INFUSION PORT BALLOON THERMODILUTION— 510(k) K833918

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K833918 for INFUSION PORT BALLOON THERMODILUTION, Substantially Equivalent on 1984-01-30. Applicant: Critikon Company, LLC.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1983-11-14
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.