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FDA 510(k)

ENGAGE/ENGAGE TR INTRODUCERS

K-Number: K111092 · 2011-06-09

ApplicantSt Jude Medical
Decision Date2011-06-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENGAGE/ENGAGE TR INTRODUCERS is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2011-06-09 under 510(k) number K111092. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGAGE/ENGAGE TR INTRODUCERS?

ENGAGE/ENGAGE TR INTRODUCERS is a medical device that received FDA 510(k) clearance on 2011-06-09. The listed applicant is St Jude Medical. The 510(k) number is K111092.

When did ENGAGE/ENGAGE TR INTRODUCERS receive FDA 510(k) clearance?

ENGAGE/ENGAGE TR INTRODUCERS received FDA 510(k) clearance on 2011-06-09, under 510(k) number K111092.

Who is the listed applicant for ENGAGE/ENGAGE TR INTRODUCERS?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENGAGE/ENGAGE TR INTRODUCERS?

The FDA product code for ENGAGE/ENGAGE TR INTRODUCERS is DYB.

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Related Devices (Code: DYB)

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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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