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FDA 510(k)

Elite HV Radial

K-Number: K173287 · 2017-12-21

ApplicantGalt Medical Corp.
Decision Date2017-12-21
Product CodeDYB
Advisory CommitteeCV
DecisionUnknown

Device Summary

Elite HV Radial is the device name listed in this FDA 510(k) record. The listed applicant is Galt Medical Corp.. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K173287. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Elite HV Radial?

Elite HV Radial is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Galt Medical Corp.. The 510(k) number is K173287.

When did Elite HV Radial receive FDA 510(k) clearance?

Elite HV Radial received FDA 510(k) clearance on 2017-12-21, under 510(k) number K173287.

Who is the listed applicant for Elite HV Radial?

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

What is the FDA product code for Elite HV Radial?

The FDA product code for Elite HV Radial is DYB.

Other records listing Galt Medical Corp. 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.

K192195Sterile DilatorK182660GaltTWSK172487Coaxial Dilator Set (Micro-Introducer)K153533Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

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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