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FDA 510(k)

FIBERNET EMBOLIC PROTECTION DEVICE

K-Number: K111987 · 2011-08-17

ApplicantLumen Biomedical, Inc.
Decision Date2011-08-17
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FIBERNET EMBOLIC PROTECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Lumen Biomedical, Inc.. It received FDA 510(k) clearance on 2011-08-17 under 510(k) number K111987. 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 FIBERNET EMBOLIC PROTECTION DEVICE?

FIBERNET EMBOLIC PROTECTION DEVICE is a medical device that received FDA 510(k) clearance on 2011-08-17. The listed applicant is Lumen Biomedical, Inc.. The 510(k) number is K111987.

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

FIBERNET EMBOLIC PROTECTION DEVICE received FDA 510(k) clearance on 2011-08-17, under 510(k) number K111987.

Who is the listed applicant for FIBERNET EMBOLIC PROTECTION DEVICE?

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

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

The FDA product code for FIBERNET EMBOLIC PROTECTION DEVICE 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 Lumen Biomedical, 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.

K082348FIBERNET EMBOLIC PROTECTION SYSTEMK080901LBI EMBOLECTOMY SYSTEMK071529XTRACT CATHETER SYSTEMK053372LBI CATHETER 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

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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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