Cleared Special

CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR

K130280 · Terumo Corporation · Cardiovascular
Mar 2013
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K130280 is an FDA 510(k) clearance for the CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Terumo Corporation (Elkton, US). The FDA issued a Cleared decision on March 13, 2013, 36 days after receiving the submission on February 5, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K130280 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2013
Decision Date March 13, 2013
Days to Decision 36 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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