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FDA 510(k)

SOFIA DISTAL ACCESS CATHETER

K-Number: K131482 · 2013-11-22

ApplicantMicroVention, Inc.
Decision Date2013-11-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFIA DISTAL ACCESS 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 2013-11-22 under 510(k) number K131482. 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 DISTAL ACCESS CATHETER?

SOFIA DISTAL ACCESS CATHETER is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is MicroVention, Inc.. The 510(k) number is K131482.

When did SOFIA DISTAL ACCESS CATHETER receive FDA 510(k) clearance?

SOFIA DISTAL ACCESS CATHETER received FDA 510(k) clearance on 2013-11-22, under 510(k) number K131482.

Who is the listed applicant for SOFIA DISTAL ACCESS 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 DISTAL ACCESS CATHETER?

The FDA product code for SOFIA DISTAL ACCESS CATHETER is DQY.

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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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