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FDA 510(k)

EmboTrap ll Revascularization Device

K-Number: K173452 · 2018-05-09

ApplicantNeuravi, Ltd.
Decision Date2018-05-09
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EmboTrap ll Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Neuravi, Ltd.. It received FDA 510(k) clearance on 2018-05-09 under 510(k) number K173452. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmboTrap ll Revascularization Device?

EmboTrap ll Revascularization Device is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Neuravi, Ltd.. The 510(k) number is K173452.

When did EmboTrap ll Revascularization Device receive FDA 510(k) clearance?

EmboTrap ll Revascularization Device received FDA 510(k) clearance on 2018-05-09, under 510(k) number K173452.

Who is the listed applicant for EmboTrap ll Revascularization Device?

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

What is the FDA product code for EmboTrap ll Revascularization Device?

The FDA product code for EmboTrap ll Revascularization Device is NRY.

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.

NCT03601702EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic StrokeRECRUITING

Other records listing Neuravi, Ltd. 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.

K251789EMBOTRAP III Revascularization DeviceK233924EMBOGUARD Balloon Guide CatheterK212340EMBOGUARD Balloon Guide CatheterK212908EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceK211338EMBOTRAP III Revascularization DeviceK193063EMBOTRAP III Revascularization Device

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Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited

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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