FDA 510(k)

GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004

K-Number: K041981 · 2004-08-20

Decision Date2004-08-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation. It received FDA 510(k) clearance on 2004-08-20 under 510(k) number K041981. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004?

GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 is a medical device that received FDA 510(k) clearance on 2004-08-20. The listed applicant is Guidant Corporation. The 510(k) number is K041981.

When did GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 receive FDA 510(k) clearance?

GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 received FDA 510(k) clearance on 2004-08-20, under 510(k) number K041981.

Who is the listed applicant for GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004?

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

What is the FDA product code for GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004?

The FDA product code for GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 is GEI.

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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.