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FDA 510(k)

TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM

K-Number: K071521 · 2007-11-21

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2007-11-21
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2007-11-21 under 510(k) number K071521. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM?

TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-21. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K071521.

When did TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2007-11-21, under 510(k) number K071521.

Who is the listed applicant for TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM?

The FDA product code for TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM is DWC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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