HEPARINIZED ARTERIAL SCREEN BLOOD FILTER— 510(k) K900758

Name: FDA 510(k) clearance K900758
Creator: U.S. Food and Drug Administration
Published: 1990-05-17

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K900758 for HEPARINIZED ARTERIAL SCREEN BLOOD FILTER, Substantially Equivalent on 1990-05-17. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1990-02-16
Decision date: 1990-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.