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FDA 510(k)

SOFIA EX Intracranial Support Catheter

K-Number: K230775 · 2023-09-14

ApplicantMicroVention, Inc.
Decision Date2023-09-14
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFIA EX Intracranial Support Catheter is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2023-09-14 under approval number K230775. 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 SOFIA EX Intracranial Support Catheter?

SOFIA EX Intracranial Support Catheter is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by MicroVention, Inc.. The 510(k) number is K230775.

When was SOFIA EX Intracranial Support Catheter approved by the FDA?

SOFIA EX Intracranial Support Catheter received FDA 510(k) clearance on 2023-09-14, under approval number K230775.

What company makes SOFIA EX Intracranial Support Catheter?

SOFIA EX Intracranial Support Catheter is manufactured by MicroVention, Inc..

What is the FDA product code for SOFIA EX Intracranial Support Catheter?

The FDA product code for SOFIA EX Intracranial Support Catheter is QJP.

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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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