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FDA 510(k)

ULTIMUM/ENGAGE/ENGAGE TR

K-Number: K091137 · 2009-04-22

ApplicantSt Jude Medical
Decision Date2009-04-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTIMUM/ENGAGE/ENGAGE TR 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 2009-04-22 under 510(k) number K091137. 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 ULTIMUM/ENGAGE/ENGAGE TR?

ULTIMUM/ENGAGE/ENGAGE TR is a medical device that received FDA 510(k) clearance on 2009-04-22. The listed applicant is St Jude Medical. The 510(k) number is K091137.

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

ULTIMUM/ENGAGE/ENGAGE TR received FDA 510(k) clearance on 2009-04-22, under 510(k) number K091137.

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

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 ULTIMUM/ENGAGE/ENGAGE TR?

The FDA product code for ULTIMUM/ENGAGE/ENGAGE TR 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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