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FDA 510(k)

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

K-Number: K112050 · 2011-11-18

ApplicantBiosense Webster, Inc.
Decision Date2011-11-18
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER 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 2011-11-18 under 510(k) number K112050. 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 ECO DIAGNOSTIC ULTRASOUND CATHETER?

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K112050.

When did SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER receive FDA 510(k) clearance?

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER received FDA 510(k) clearance on 2011-11-18, under 510(k) number K112050.

Who is the listed applicant for SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER?

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 ECO DIAGNOSTIC ULTRASOUND CATHETER?

The FDA product code for SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER is OBJ.

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Other records listing Biosense Webster, Inc. as applicant

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Related Devices (Code: OBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.

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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