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FDA 510(k)

Peel-Away Introducer Set

K-Number: K170020 · 2017-09-28

ApplicantCook Incorporated
Decision Date2017-09-28
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Peel-Away Introducer 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 2017-09-28 under 510(k) number K170020. 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 Peel-Away Introducer Set?

Peel-Away Introducer Set is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Cook Incorporated. The 510(k) number is K170020.

When did Peel-Away Introducer Set receive FDA 510(k) clearance?

Peel-Away Introducer Set received FDA 510(k) clearance on 2017-09-28, under 510(k) number K170020.

Who is the listed applicant for Peel-Away Introducer 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 Peel-Away Introducer Set?

The FDA product code for Peel-Away Introducer Set is DYB.

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture 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, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo 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.

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