FDA 510(k)

HEPARINASE HR ACT CONTROL, MODEL 550-12

K-Number: K042175 · 2004-10-18

Decision Date2004-10-18

Product CodeGGN

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HEPARINASE HR ACT CONTROL, MODEL 550-12 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2004-10-18 under 510(k) number K042175. 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 HEPARINASE HR ACT CONTROL, MODEL 550-12?

HEPARINASE HR ACT CONTROL, MODEL 550-12 is a medical device that received FDA 510(k) clearance on 2004-10-18. The listed applicant is Medtronic Vascular. The 510(k) number is K042175.

When did HEPARINASE HR ACT CONTROL, MODEL 550-12 receive FDA 510(k) clearance?

HEPARINASE HR ACT CONTROL, MODEL 550-12 received FDA 510(k) clearance on 2004-10-18, under 510(k) number K042175.

Who is the listed applicant for HEPARINASE HR ACT CONTROL, MODEL 550-12?

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

What is the FDA product code for HEPARINASE HR ACT CONTROL, MODEL 550-12?

The FDA product code for HEPARINASE HR ACT CONTROL, MODEL 550-12 is GGN.

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Official Source

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