TERUMO GAS FILTER— 510(k) K021020

Substantially Equivalent

Terumo Cardiovascular Systems Corp.

FDA 510(k) clearance K021020 for TERUMO GAS FILTER, Substantially Equivalent on 2002-06-10. Applicant: Terumo Cardiovascular Systems Corp..

Clearance details

Applicant
Terumo Cardiovascular Systems Corp.
Product code
Code CAH
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Elkton, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAH

product code CAH
Death
7
Total
7

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.