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FDA 510(k)

ASCENDX VCF REDUCTION SYSTEM

K-Number: K100404 · 2012-12-14

ApplicantAoi Medical, Inc.
Decision Date2012-12-14
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENDX VCF REDUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aoi Medical, Inc.. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K100404. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENDX VCF REDUCTION SYSTEM?

ASCENDX VCF REDUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Aoi Medical, Inc.. The 510(k) number is K100404.

When did ASCENDX VCF REDUCTION SYSTEM receive FDA 510(k) clearance?

ASCENDX VCF REDUCTION SYSTEM received FDA 510(k) clearance on 2012-12-14, under 510(k) number K100404.

Who is the listed applicant for ASCENDX VCF REDUCTION SYSTEM?

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

What is the FDA product code for ASCENDX VCF REDUCTION SYSTEM?

The FDA product code for ASCENDX VCF REDUCTION SYSTEM is NDN.

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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.

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