ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3— 510(k) K122940

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K122940 for ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3, Substantially Equivalent on 2013-03-19. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2012-09-24
Decision date: 2013-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.