HARMAC THERMODILUTION CATHETER— 510(k) K963336

Substantially Equivalent

Harmac Medical Products, Inc.

FDA 510(k) clearance K963336 for HARMAC THERMODILUTION CATHETER, Substantially Equivalent on 1997-08-14. Applicant: Harmac Medical Products, Inc..

Clearance details

Applicant: Harmac Medical Products, Inc.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1996-06-28
Decision date: 1997-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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.