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FDA 510(k)

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

K-Number: K162181 · 2017-01-06

ApplicantCardiacassist, Inc.
Decision Date2017-01-06
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2017-01-06 under approval number K162181. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K162181.

When was Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set approved by the FDA?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set received FDA 510(k) clearance on 2017-01-06, under approval number K162181.

What company makes Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is manufactured by Cardiacassist, Inc..

What is the FDA product code for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

The FDA product code for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is DRE.

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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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