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FDA 510(k)

ENSITE VELOCITY SYSTEM

K-Number: K101328 · 2010-07-14

ApplicantSt Jude Medical
Decision Date2010-07-14
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENSITE VELOCITY SYSTEM 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 2010-07-14 under 510(k) number K101328. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSITE VELOCITY SYSTEM?

ENSITE VELOCITY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-14. The listed applicant is St Jude Medical. The 510(k) number is K101328.

When did ENSITE VELOCITY SYSTEM receive FDA 510(k) clearance?

ENSITE VELOCITY SYSTEM received FDA 510(k) clearance on 2010-07-14, under 510(k) number K101328.

Who is the listed applicant for ENSITE VELOCITY SYSTEM?

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 ENSITE VELOCITY SYSTEM?

The FDA product code for ENSITE VELOCITY SYSTEM is DQK.

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Related Devices (Code: DQK)

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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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