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FDA 510(k)

EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

K-Number: K092596 · 2009-12-10

ApplicantVolcano Corporation
Decision Date2009-12-10
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EAGLE EYE PLATINUM DIGITAL IVUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2009-12-10 under 510(k) number K092596. 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 EAGLE EYE PLATINUM DIGITAL IVUS CATHETER?

EAGLE EYE PLATINUM DIGITAL IVUS CATHETER is a medical device that received FDA 510(k) clearance on 2009-12-10. The listed applicant is Volcano Corporation. The 510(k) number is K092596.

When did EAGLE EYE PLATINUM DIGITAL IVUS CATHETER receive FDA 510(k) clearance?

EAGLE EYE PLATINUM DIGITAL IVUS CATHETER received FDA 510(k) clearance on 2009-12-10, under 510(k) number K092596.

Who is the listed applicant for EAGLE EYE PLATINUM DIGITAL IVUS CATHETER?

The FDA 510(k) record lists Volcano Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EAGLE EYE PLATINUM DIGITAL IVUS CATHETER?

The FDA product code for EAGLE EYE PLATINUM DIGITAL IVUS CATHETER is OBJ.

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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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