HARMAC BALLOON WEDGE PRESSURE CATHETER— 510(k) K963335

Substantially Equivalent

Harmac Medical Products, Inc.

FDA 510(k) clearance K963335 for HARMAC BALLOON WEDGE PRESSURE CATHETER, Substantially Equivalent on 1997-10-16. Applicant: Harmac Medical Products, Inc..

Clearance details

Applicant: Harmac Medical Products, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1996-06-28
Decision date: 1997-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.