SWANK ARTERIAL LINE BLOOD FILTER HF6000— 510(k) K855066

Name: FDA 510(k) clearance K855066
Creator: U.S. Food and Drug Administration
Published: 1986-02-26

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K855066 for SWANK ARTERIAL LINE BLOOD FILTER HF6000, Substantially Equivalent on 1986-02-26. 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: 1985-12-18
Decision date: 1986-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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