Cleared Traditional

K802970 - TERUMO HOLLOW FIBER OXYGENATOR
(FDA 510(k) Clearance)

K802970 · Terumo America, Inc. · Cardiovascular
Jan 1981
Decision
62d
Days
Class 2
Risk

K802970 is an FDA 510(k) clearance for the TERUMO HOLLOW FIBER OXYGENATOR. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ).

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1981, 62 days after receiving the submission on November 21, 1980.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K802970 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1980
Decision Date January 22, 1981
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

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

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