INTRAOPERATIVE BALLOON DILATION CATH.— 510(k) K822393

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K822393 for INTRAOPERATIVE BALLOON DILATION CATH., Substantially Equivalent on 1982-11-01. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1982-08-09
Decision date: 1982-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.