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FDA 510(k)

Synchro2 Support Guidewire

K-Number: K190843 · 2019-05-01

ApplicantStryker
Decision Date2019-05-01
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Synchro2 Support Guidewire is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2019-05-01 under approval number K190843. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synchro2 Support Guidewire?

Synchro2 Support Guidewire is a medical device that received FDA 510(k) clearance on 2019-05-01. It is manufactured by Stryker. The 510(k) number is K190843.

When was Synchro2 Support Guidewire approved by the FDA?

Synchro2 Support Guidewire received FDA 510(k) clearance on 2019-05-01, under approval number K190843.

What company makes Synchro2 Support Guidewire?

Synchro2 Support Guidewire is manufactured by Stryker.

What is the FDA product code for Synchro2 Support Guidewire?

The FDA product code for Synchro2 Support Guidewire is MOF.

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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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