CAPIOX ARTERIAL FILTER— 510(k) K943917

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K943917 for CAPIOX ARTERIAL FILTER, Substantially Equivalent on 1995-07-25. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1994-08-11
Decision date: 1995-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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.