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FDA 510(k)

THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM

K-Number: K052454 · 2005-09-14

ApplicantAbbott Vascular Devices
Decision Date2005-09-14
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular Devices. It received FDA 510(k) clearance on 2005-09-14 under 510(k) number K052454. 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 THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM?

THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is Abbott Vascular Devices. The 510(k) number is K052454.

When did THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM receive FDA 510(k) clearance?

THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM received FDA 510(k) clearance on 2005-09-14, under 510(k) number K052454.

Who is the listed applicant for THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM?

The FDA 510(k) record lists Abbott Vascular Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM?

The FDA product code for THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM 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 Abbott Vascular Devices 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.

K050501MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

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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