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FDA 510(k)

GALTSTICK INTRODUCER SYSTEM

K-Number: K071330 · 2007-10-31

ApplicantGalt Medical Corp.
Decision Date2007-10-31
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALTSTICK INTRODUCER SYSTEM 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 2007-10-31 under 510(k) number K071330. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALTSTICK INTRODUCER SYSTEM?

GALTSTICK INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-31. The listed applicant is Galt Medical Corp.. The 510(k) number is K071330.

When did GALTSTICK INTRODUCER SYSTEM receive FDA 510(k) clearance?

GALTSTICK INTRODUCER SYSTEM received FDA 510(k) clearance on 2007-10-31, under 510(k) number K071330.

Who is the listed applicant for GALTSTICK INTRODUCER SYSTEM?

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 GALTSTICK INTRODUCER SYSTEM?

The FDA product code for GALTSTICK INTRODUCER SYSTEM is DRE.

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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)K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerK123430MICROSLIDER TEARAWAY INTRODUCER SET

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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