JACKET & SET— 510(k) K823533

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K823533 for JACKET & SET, Substantially Equivalent on 1982-12-30. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1982-11-29
Decision date: 1982-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.