TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER— 510(k) K884375

Substantially Equivalent

Argon Medical Corp.

FDA 510(k) clearance K884375 for TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER, Substantially Equivalent on 1989-01-11. Applicant: Argon Medical Corp..

Clearance details

Applicant: Argon Medical Corp.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1988-10-18
Decision date: 1989-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQR

product code DQR

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.