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FDA 510(k)

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

K-Number: K964061 · 1997-02-20

ApplicantW. L. Gore & Associates, Inc.
Decision Date1997-02-20
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K964061. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)?

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K964061.

When did GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) receive FDA 510(k) clearance?

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) received FDA 510(k) clearance on 1997-02-20, under 510(k) number K964061.

Who is the listed applicant for GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)?

The FDA product code for GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) is LYK.

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Other records listing W. L. Gore & Associates, Inc. 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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Related Devices (Code: LYK)

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.

K253842Vena MicroAngioscope™ SystemVena Medical Holdings CorpK251767Vena MicroAngioscope™ SystemVena Medical Holdings CorpK062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, 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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