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FDA 510(k)

HQS INTRODUCER

K-Number: K113849 · 2012-07-31

ApplicantAlseal
Decision Date2012-07-31
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HQS INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Alseal. It received FDA 510(k) clearance on 2012-07-31 under 510(k) number K113849. 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?

HQS INTRODUCER is a medical device that received FDA 510(k) clearance on 2012-07-31. The listed applicant is Alseal. The 510(k) number is K113849.

When did HQS INTRODUCER receive FDA 510(k) clearance?

HQS INTRODUCER received FDA 510(k) clearance on 2012-07-31, under 510(k) number K113849.

Who is the listed applicant for HQS INTRODUCER?

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?

The FDA product code for HQS INTRODUCER is DYB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alseal as applicant

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.

K153494HQS Introducer (Model 2064-HQS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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