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FDA 510(k)

SOFIA Plus Aspiration Catheter

K-Number: K173200 · 2018-06-11

Decision Date2018-06-11
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFIA Plus Aspiration Catheter is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2018-06-11 under approval number K173200. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFIA Plus Aspiration Catheter?

SOFIA Plus Aspiration Catheter is a medical device that received FDA 510(k) clearance on 2018-06-11. It is manufactured by MicroVention, Inc.. The 510(k) number is K173200.

When was SOFIA Plus Aspiration Catheter approved by the FDA?

SOFIA Plus Aspiration Catheter received FDA 510(k) clearance on 2018-06-11, under approval number K173200.

What company makes SOFIA Plus Aspiration Catheter?

SOFIA Plus Aspiration Catheter is manufactured by MicroVention, Inc..

What is the FDA product code for SOFIA Plus Aspiration Catheter?

The FDA product code for SOFIA Plus Aspiration Catheter is NRY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.