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FDA 510(k)

RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM

K-Number: K042908 · 2004-11-12

ApplicantGuidant Corp.
Decision Date2004-11-12
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2004-11-12 under 510(k) number K042908. 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 RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM?

RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-12. The listed applicant is Guidant Corp.. The 510(k) number is K042908.

When did RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM receive FDA 510(k) clearance?

RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM received FDA 510(k) clearance on 2004-11-12, under 510(k) number K042908.

Who is the listed applicant for RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM?

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

What is the FDA product code for RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM?

The FDA product code for RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM is NTE.

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Other records listing Guidant 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.

K061865FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05K061453HI-TORQUE WHISPER VIEW GUIDE WIREK042218ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEMK033834OMNILINK .018 BILIARY STENT SYSTEMK033393ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEMK031678HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

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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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