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FDA 510(k)

GORE(R) EMBOLIC FILTER

K-Number: K120480 · 2012-03-16

ApplicantW.L. Gore & Associates
Decision Date2012-03-16
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE(R) EMBOLIC FILTER is the device name listed in this FDA 510(k) record. The listed applicant is W.L. Gore & Associates. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K120480. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE(R) EMBOLIC FILTER?

GORE(R) EMBOLIC FILTER is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is W.L. Gore & Associates. The 510(k) number is K120480.

When did GORE(R) EMBOLIC FILTER receive FDA 510(k) clearance?

GORE(R) EMBOLIC FILTER received FDA 510(k) clearance on 2012-03-16, under 510(k) number K120480.

Who is the listed applicant for GORE(R) EMBOLIC FILTER?

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

What is the FDA product code for GORE(R) EMBOLIC FILTER?

The FDA product code for GORE(R) EMBOLIC FILTER is NTE.

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.

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Other records listing W.L. Gore & Associates 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.

K093934GORE HYBRID VASCULAR GRAFTK053202GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

Related Devices (Code: NTE)

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.

K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road MedicalK220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis CorporationK210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.K200198WIRIONCardiovascular Systems, Inc.K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular

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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