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FDA 510(k)

EMBOTRAP III Revascularization Device

K-Number: K211338 · 2021-07-30

ApplicantNeuravi, Ltd.
Decision Date2021-07-30
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOTRAP III 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 2021-07-30 under 510(k) number K211338. 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 III Revascularization Device?

EMBOTRAP III Revascularization Device is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Neuravi, Ltd.. The 510(k) number is K211338.

When did EMBOTRAP III Revascularization Device receive FDA 510(k) clearance?

EMBOTRAP III Revascularization Device received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211338.

Who is the listed applicant for EMBOTRAP III 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 III Revascularization Device?

The FDA product code for EMBOTRAP III 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 DeviceK193063EMBOTRAP III Revascularization DeviceK173452EmboTrap ll 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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