ANGIOGRAPHIC NEEDLE— 510(k) K831189

Substantially Equivalent

Medrad, Inc.

FDA 510(k) clearance K831189 for ANGIOGRAPHIC NEEDLE, Substantially Equivalent on 1983-05-09. Applicant: Medrad, Inc..

Clearance details

Applicant: Medrad, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1983-04-12
Decision date: 1983-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.