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FDA 510(k)

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

K-Number: K081523 · 2008-09-11

ApplicantAbbott Vascular-Vascular Solutions
Decision Date2008-09-11
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular-Vascular Solutions. It received FDA 510(k) clearance on 2008-09-11 under 510(k) number K081523. 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 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM?

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Abbott Vascular-Vascular Solutions. The 510(k) number is K081523.

When did EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM receive FDA 510(k) clearance?

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM received FDA 510(k) clearance on 2008-09-11, under 510(k) number K081523.

Who is the listed applicant for EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM?

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

What is the FDA product code for EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM?

The FDA product code for EMBOSHIELD NAV6 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Abbott Vascular-Vascular Solutions 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.

K090665EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19K090509FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETERK072708ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEMK080264MODIFICATION TO: FOX PLUS PTA CATHETERK072798VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER

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

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

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