35MM ANGIOGRAM VIEWER ANALYZER— 510(k) K821491

Substantially Equivalent

Birtcher Corp.

FDA 510(k) clearance K821491 for 35MM ANGIOGRAM VIEWER ANALYZER, Substantially Equivalent on 1982-07-08. Applicant: Birtcher Corp..

Clearance details

Applicant: Birtcher Corp.
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 1982-05-18
Decision date: 1982-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXJ

product code DXJ

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.