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FDA 510(k)

SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12

K-Number: K101138 · 2010-06-22

ApplicantBiosense Webster, Inc.
Decision Date2010-06-22
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2010-06-22 under 510(k) number K101138. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12?

SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 is a medical device that received FDA 510(k) clearance on 2010-06-22. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K101138.

When did SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 receive FDA 510(k) clearance?

SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 received FDA 510(k) clearance on 2010-06-22, under 510(k) number K101138.

Who is the listed applicant for SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12?

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

What is the FDA product code for SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12?

The FDA product code for SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 is OBJ.

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Related Devices (Code: OBJ)

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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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