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FDA 510(k)

MAXIFLO, TAPERFLO

K-Number: K092863 · 2009-10-08

ApplicantVascutek, Ltd.
Decision Date2009-10-08
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAXIFLO, TAPERFLO is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2009-10-08 under 510(k) number K092863. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXIFLO, TAPERFLO?

MAXIFLO, TAPERFLO is a medical device that received FDA 510(k) clearance on 2009-10-08. The listed applicant is Vascutek, Ltd.. The 510(k) number is K092863.

When did MAXIFLO, TAPERFLO receive FDA 510(k) clearance?

MAXIFLO, TAPERFLO received FDA 510(k) clearance on 2009-10-08, under 510(k) number K092863.

Who is the listed applicant for MAXIFLO, TAPERFLO?

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

What is the FDA product code for MAXIFLO, TAPERFLO?

The FDA product code for MAXIFLO, TAPERFLO is DSY.

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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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