STOCKERT-SHILEY CAPS BATTERY MODULE— 510(k) K863960

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K863960 for STOCKERT-SHILEY CAPS BATTERY MODULE, Substantially Equivalent on 1986-12-11. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 1986-10-10
Decision date: 1986-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.