WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER— 510(k) K032069

Substantially Equivalent

AngioDynamics, Inc.

FDA 510(k) clearance K032069 for WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER, Substantially Equivalent on 2003-08-27. Applicant: AngioDynamics, Inc..

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2003-07-03
Decision date: 2003-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Queensburgy, NY, 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.