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FDA 510(k)

EMBOGUARD Balloon Guide Catheter

K-Number: K233924 · 2024-04-18

ApplicantNeuravi Limited
Decision Date2024-04-18
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOGUARD Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Neuravi Limited. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K233924. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOGUARD Balloon Guide Catheter?

EMBOGUARD Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Neuravi Limited. The 510(k) number is K233924.

When did EMBOGUARD Balloon Guide Catheter receive FDA 510(k) clearance?

EMBOGUARD Balloon Guide Catheter received FDA 510(k) clearance on 2024-04-18, under 510(k) number K233924.

Who is the listed applicant for EMBOGUARD Balloon Guide Catheter?

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

What is the FDA product code for EMBOGUARD Balloon Guide Catheter?

The FDA product code for EMBOGUARD Balloon Guide Catheter is QJP.

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.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Other records listing Neuravi Limited 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 DeviceK212340EMBOGUARD Balloon Guide CatheterK212908EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceK211338EMBOTRAP III Revascularization DeviceK193063EMBOTRAP III Revascularization DeviceK173452EmboTrap ll Revascularization Device

View all 7 devices →

Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou 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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