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FDA 510(k)

ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)

K-Number: K101667 · 2010-07-02

ApplicantSt Jude Medical
Decision Date2010-07-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) 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 2010-07-02 under 510(k) number K101667. 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 REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)?

ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) is a medical device that received FDA 510(k) clearance on 2010-07-02. The listed applicant is St Jude Medical. The 510(k) number is K101667.

When did ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) receive FDA 510(k) clearance?

ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) received FDA 510(k) clearance on 2010-07-02, under 510(k) number K101667.

Who is the listed applicant for ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)?

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 REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)?

The FDA product code for ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) is DQK.

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Related Devices (Code: DQK)

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K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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