FLOW-DIRECTED BALLOON THERMODILUTION— 510(k) K812761

Substantially Equivalent

Nova Medical Specialties

FDA 510(k) clearance K812761 for FLOW-DIRECTED BALLOON THERMODILUTION, Substantially Equivalent on 1981-11-02. Applicant: Nova Medical Specialties.

Clearance details

Applicant: Nova Medical Specialties
Product code: Code KRG
Advisory panel: Cardiovascular
Date received: 1981-10-01
Decision date: 1981-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KRG

product code KRG

Malfunction: 8,377
Total: 8,377

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.