ATS Y ADAPTER CODE #2452— 510(k) K900299

Substantially Equivalent

Artium Medical Corp.

FDA 510(k) clearance K900299 for ATS Y ADAPTER CODE #2452, Substantially Equivalent on 1990-05-01. Applicant: Artium Medical Corp..

Clearance details

Applicant
Artium Medical Corp.
Product code
Code CAC
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hollis, NH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAC

product code CAC
Death
11
Malfunction
477
Total
488

Source: openFDA MAUDE database, through . 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.