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FDA 510(k)

EMBOGUARD Balloon Guide Catheter

K-Number: K212340 · 2021-12-17

ApplicantNeuravi Limited
Decision Date2021-12-17
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOGUARD Balloon Guide Catheter is a medical device manufactured by Neuravi Limited. It received FDA 510(k) clearance on 2021-12-17 under approval number K212340. 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 2021-12-17. It is manufactured by Neuravi Limited. The 510(k) number is K212340.

When was EMBOGUARD Balloon Guide Catheter approved by the FDA?

EMBOGUARD Balloon Guide Catheter received FDA 510(k) clearance on 2021-12-17, under approval number K212340.

What company makes EMBOGUARD Balloon Guide Catheter?

EMBOGUARD Balloon Guide Catheter is manufactured by Neuravi Limited.

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

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Other Devices by Neuravi Limited

K233924EMBOGUARD Balloon Guide Catheter K251789EMBOTRAP III Revascularization Device

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, Inc.

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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