FDA 510(k)

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set

K-Number: K171609 · 2018-06-04

Decision Date2018-06-04

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-06-04 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K171609.

When did Check-Flo Performer Introducer Micropuncture Radial Artery Access Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Check-Flo Performer Introducer Micropuncture Radial Artery Access Set?

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

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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Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.