Terumo Hollow Fiber Oxygenator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K802970 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Terumo America, Inc. →

• What is the primary function of the Terumo Hollow Fiber Oxygenator?

  This device is a cardiopulmonary bypass oxygenator designed to facilitate essential gas exchange for patients during surgical procedures that require extracorporeal circulation.

• How is this device classified for regulatory purposes?

  The Terumo Hollow Fiber Oxygenator is classified as a class 2 medical device under regulation number 870.4350. It is identified by FDA 510(k) number K802970.

• Which medical specialty uses this oxygenator?

  This device is utilized within the cardiovascular specialty, as it is specifically engineered for procedures involving cardiopulmonary bypass and extracorporeal circulation.