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FDA 510(k)

SOFIA EX Intracranial Support Catheter

K-Number: K182602 · 2019-05-15

ApplicantMicroVention, Inc.
Decision Date2019-05-15
Product CodeDQY
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 2019-05-15 under approval number K182602. The device is classified under product code DQY. 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 2019-05-15. It is manufactured by MicroVention, Inc.. The 510(k) number is K182602.

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

SOFIA EX Intracranial Support Catheter received FDA 510(k) clearance on 2019-05-15, under approval number K182602.

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 DQY.

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Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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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