ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101— 510(k) K010253

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K010253 for ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101, Substantially Equivalent on 2002-03-19. Applicant: Transonic Systems, Inc..

Clearance details

Applicant: Transonic Systems, Inc.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 2001-01-26
Decision date: 2002-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, 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.