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FDA 510(k)

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set

K-Number: K171609 · 2018-06-04

ApplicantCook Incorporated
Decision Date2018-06-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-06-04 under approval number K171609. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Check-Flo Performer Introducer Micropuncture Radial Artery Access Set?

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set is a medical device that received FDA 510(k) clearance on 2018-06-04. It is manufactured by Cook Incorporated. The 510(k) number is K171609.

When was Check-Flo Performer Introducer Micropuncture Radial Artery Access Set approved by the FDA?

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set received FDA 510(k) clearance on 2018-06-04, under approval number K171609.

What company makes Check-Flo Performer Introducer Micropuncture Radial Artery Access Set?

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set is manufactured by Cook Incorporated.

What is the FDA product code for Check-Flo Performer Introducer Micropuncture Radial Artery Access Set?

The FDA product code for Check-Flo Performer Introducer Micropuncture Radial Artery Access Set is DYB.

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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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