Terumo HX2 Temperature Management System

FDA 510(k) K071521 · Terumo Cardiovascular Systems Corp.

Substantially Equivalent

510(k) numberK071521

Submission

Device name
Terumo HX2 Temperature Management System
Applicant
Terumo Cardiovascular Systems Corp.
Ann Arbor, MI, US
Received
June 4, 2007
Decision date
November 21, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWC – Controller, Temperature, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4250
Specialty
Cardiovascular
Life-sustaining
Yes

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was Terumo HX2 Temperature Management System cleared by the FDA?

Terumo HX2 Temperature Management System (K071521) received a 510(k) decision of Substantially Equivalent on November 21, 2007, 170 days after the submission was received.

What is the product code of K071521?

The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.