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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 the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2022-09-12 under 510(k) 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. The listed applicant is MicroVention, Inc.. The 510(k) number is K214024.

When did SOFIA 88 Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for SOFIA 88 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 88 Catheter?

The FDA product code for SOFIA 88 Catheter is 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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