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FDA 510(k)

SPIDERX EMBOLIC PROTECTION DEVICE

K-Number: K052659 · 2006-02-17

ApplicantEv3, Inc.
Decision Date2006-02-17
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPIDERX EMBOLIC PROTECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ev3, Inc.. It received FDA 510(k) clearance on 2006-02-17 under 510(k) number K052659. 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 SPIDERX EMBOLIC PROTECTION DEVICE?

SPIDERX EMBOLIC PROTECTION DEVICE is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Ev3, Inc.. The 510(k) number is K052659.

When did SPIDERX EMBOLIC PROTECTION DEVICE receive FDA 510(k) clearance?

SPIDERX EMBOLIC PROTECTION DEVICE received FDA 510(k) clearance on 2006-02-17, under 510(k) number K052659.

Who is the listed applicant for SPIDERX EMBOLIC PROTECTION DEVICE?

The FDA 510(k) record lists Ev3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIDERX EMBOLIC PROTECTION DEVICE?

The FDA product code for SPIDERX EMBOLIC PROTECTION DEVICE is NTE.

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Other records listing Ev3, 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.

K132777NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETERK130911RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETERK123544RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETERK111010SPIDERFX EMBOLIC PROTECTION DEVICEK111723TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMK111490MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS

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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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