CAPIOX BUBBLE TRAP WITH X-COATING— 510(k) K090698

Name: FDA 510(k) clearance K090698
Creator: U.S. Food and Drug Administration
Published: 2009-06-08

Substantially Equivalent

Terumo Cardiovascular Systems

FDA 510(k) clearance K090698 for CAPIOX BUBBLE TRAP WITH X-COATING, Substantially Equivalent on 2009-06-08. Applicant: Terumo Cardiovascular Systems. Device class: 2.

Clearance details

Applicant: Terumo Cardiovascular Systems
Product code: Code KRL
Device class: Class 2
Regulation: 21 CFR 870.4205
Advisory panel: Cardiovascular
Date received: 2009-03-17
Decision date: 2009-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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