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FDA 510(k)

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

K-Number: K153533 · 2016-07-05

ApplicantGalt Medical Corp.
Decision Date2016-07-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer 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 2016-07-05 under 510(k) number K153533. 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 Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is a medical device that received FDA 510(k) clearance on 2016-07-05. The listed applicant is Galt Medical Corp.. The 510(k) number is K153533.

When did Tearaway Introducer Sheath, MicroSlide Tearaway Introducer receive FDA 510(k) clearance?

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer received FDA 510(k) clearance on 2016-07-05, under 510(k) number K153533.

Who is the listed applicant for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

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 Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

The FDA product code for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer 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 DilatorK182660GaltTWSK173287Elite HV RadialK172487Coaxial Dilator Set (Micro-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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