FDA 510(k)

JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900

K-Number: K031346 · 2003-06-23

Decision Date2003-06-23

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 is the device name listed in this FDA 510(k) record. The listed applicant is Jomed, Inc.. It received FDA 510(k) clearance on 2003-06-23 under 510(k) number K031346. 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 JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900?

JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 is a medical device that received FDA 510(k) clearance on 2003-06-23. The listed applicant is Jomed, Inc.. The 510(k) number is K031346.

When did JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 receive FDA 510(k) clearance?

JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 received FDA 510(k) clearance on 2003-06-23, under 510(k) number K031346.

Who is the listed applicant for JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900?

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

What is the FDA product code for JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900?

The FDA product code for JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 is OBJ.

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Other records listing Jomed, Inc. as applicant

K031148IN-VISION IMAGING SYSTEM K031277JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 K022762JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 K021219SMARTWIRE/SMARTMAP PRESSURE SYSTEM K003938TRAK BACK II

Related Devices (Code: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight 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 Scientific K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device K250955XC11 ICE System, USAYorlabs, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.