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FDA 510(k)

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

K-Number: K103314 · 2010-12-03

ApplicantMedtronic, Inc.
Decision Date2010-12-03
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K103314. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL?

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Medtronic, Inc.. The 510(k) number is K103314.

When did CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL receive FDA 510(k) clearance?

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL received FDA 510(k) clearance on 2010-12-03, under 510(k) number K103314.

Who is the listed applicant for CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL?

The FDA product code for CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL is GGN.

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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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