FDA 510(k)

ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

K-Number: K062531 · 2006-09-22

ApplicantCordis Corp., A Johnson & Johnson Co.

Decision Date2006-09-22

Product CodeNTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. It received FDA 510(k) clearance on 2006-09-22 under 510(k) number K062531. 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 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE?

ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. The 510(k) number is K062531.

When did ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE receive FDA 510(k) clearance?

ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE received FDA 510(k) clearance on 2006-09-22, under 510(k) number K062531.

Who is the listed applicant for ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE?

The FDA 510(k) record lists Cordis Corp., A Johnson & Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE?

The FDA product code for ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE is NTE.

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Other records listing Cordis Corp., A Johnson & Johnson Co. as applicant

K131225ADROIT GUIDING CATHETER K091077OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER K083814OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120

Related Devices (Code: NTE)

K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.K200198WIRIONCardiovascular Systems, Inc.K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.