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FDA 510(k)

Sorin Connect

K-Number: K170460 · 2017-06-08

ApplicantSorin Group Deutschland GmbH
Decision Date2017-06-08
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sorin Connect is a medical device manufactured by Sorin Group Deutschland GmbH. It received FDA 510(k) clearance on 2017-06-08 under approval number K170460. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sorin Connect?

Sorin Connect is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Sorin Group Deutschland GmbH. The 510(k) number is K170460.

When was Sorin Connect approved by the FDA?

Sorin Connect received FDA 510(k) clearance on 2017-06-08, under approval number K170460.

What company makes Sorin Connect?

Sorin Connect is manufactured by Sorin Group Deutschland GmbH.

What is the FDA product code for Sorin Connect?

The FDA product code for Sorin Connect is DXJ.

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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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