K862116

Substantially Equivalent

STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE

Applicant: Shiley, Inc.
Product code: DWB
Advisory panel: Cardiovascular
Date received: 1986-06-03
Decision date: 1986-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code DWB

product code DWB

Death: 2
Total: 2

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.