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FDA 510(k)

6F PROXIS SYSTEM

K-Number: K073700 · 2008-10-02

ApplicantSt. Jude Medical, Inc.
Decision Date2008-10-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

6F PROXIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2008-10-02 under 510(k) number K073700. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6F PROXIS SYSTEM?

6F PROXIS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K073700.

When did 6F PROXIS SYSTEM receive FDA 510(k) clearance?

6F PROXIS SYSTEM received FDA 510(k) clearance on 2008-10-02, under 510(k) number K073700.

Who is the listed applicant for 6F PROXIS SYSTEM?

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

What is the FDA product code for 6F PROXIS SYSTEM?

The FDA product code for 6F PROXIS SYSTEM is DQY.

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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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