BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET— 510(k) K900186

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K900186 for BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET, Substantially Equivalent on 1990-04-10. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1990-01-16
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.