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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 the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) 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. The listed applicant is MicroVention, Inc.. The 510(k) number is K182602.

When did SOFIA EX Intracranial Support Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for SOFIA EX Intracranial Support Catheter?

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

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

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

Other records listing MicroVention, Inc. as applicant

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Related Devices (Code: DQY)

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.

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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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