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FDA 510(k)

AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

K-Number: K063712 · 2007-03-12

ApplicantC.R. Bard, Inc.
Decision Date2007-03-12
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2007-03-12 under 510(k) number K063712. The device is classified under product code OTP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM?

AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-12. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K063712.

When did AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM receive FDA 510(k) clearance?

AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM received FDA 510(k) clearance on 2007-03-12, under 510(k) number K063712.

Who is the listed applicant for AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM?

The FDA product code for AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM is OTP.

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Official Source

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