DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION— 510(k) K914985

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K914985 for DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION, Substantially Equivalent on 1991-12-20. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 1991-10-23
Decision date: 1991-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.