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FDA 510(k)

SOFIA 88 Catheter

K-Number: K214024 · 2022-09-12

ApplicantMicroVention, Inc.
Decision Date2022-09-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFIA 88 Catheter is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2022-09-12 under approval number K214024. 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 88 Catheter?

SOFIA 88 Catheter is a medical device that received FDA 510(k) clearance on 2022-09-12. It is manufactured by MicroVention, Inc.. The 510(k) number is K214024.

When was SOFIA 88 Catheter approved by the FDA?

SOFIA 88 Catheter received FDA 510(k) clearance on 2022-09-12, under approval number K214024.

What company makes SOFIA 88 Catheter?

SOFIA 88 Catheter is manufactured by MicroVention, Inc..

What is the FDA product code for SOFIA 88 Catheter?

The FDA product code for SOFIA 88 Catheter is DQY.

Related Clinical Trials

NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING

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Related Devices (Code: DQY)

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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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