CORDIS ANGIOPLASTY HEMOSTASIS DEVICES— 510(k) K863177

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K863177 for CORDIS ANGIOPLASTY HEMOSTASIS DEVICES, Substantially Equivalent on 1986-10-15. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1986-08-18
Decision date: 1986-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.