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FDA 510(k)

HQS Introducer (Model 2064-HQS)

K-Number: K153494 · 2016-08-25

ApplicantAlseal
Decision Date2016-08-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HQS Introducer (Model 2064-HQS) is the device name listed in this FDA 510(k) record. The listed applicant is Alseal. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K153494. 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 HQS Introducer (Model 2064-HQS)?

HQS Introducer (Model 2064-HQS) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Alseal. The 510(k) number is K153494.

When did HQS Introducer (Model 2064-HQS) receive FDA 510(k) clearance?

HQS Introducer (Model 2064-HQS) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K153494.

Who is the listed applicant for HQS Introducer (Model 2064-HQS)?

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

What is the FDA product code for HQS Introducer (Model 2064-HQS)?

The FDA product code for HQS Introducer (Model 2064-HQS) is DYB.

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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