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FDA 510(k)

AUGEASE VASCULAR AUGMENTATION DEVICE

K-Number: K101355 · 2010-10-26

ApplicantAugdvt, LLC
Decision Date2010-10-26
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUGEASE VASCULAR AUGMENTATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Augdvt, LLC. It received FDA 510(k) clearance on 2010-10-26 under 510(k) number K101355. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUGEASE VASCULAR AUGMENTATION DEVICE?

AUGEASE VASCULAR AUGMENTATION DEVICE is a medical device that received FDA 510(k) clearance on 2010-10-26. The listed applicant is Augdvt, LLC. The 510(k) number is K101355.

When did AUGEASE VASCULAR AUGMENTATION DEVICE receive FDA 510(k) clearance?

AUGEASE VASCULAR AUGMENTATION DEVICE received FDA 510(k) clearance on 2010-10-26, under 510(k) number K101355.

Who is the listed applicant for AUGEASE VASCULAR AUGMENTATION DEVICE?

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

What is the FDA product code for AUGEASE VASCULAR AUGMENTATION DEVICE?

The FDA product code for AUGEASE VASCULAR AUGMENTATION DEVICE is JOW.

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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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