FDA 510(k)

VISIONS PV .035 DITITAL IVUS CATHETER

K-Number: K121273 · 2012-09-10

Decision Date2012-09-10

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VISIONS PV .035 DITITAL 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 2012-09-10 under 510(k) number K121273. 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 VISIONS PV .035 DITITAL IVUS CATHETER?

VISIONS PV .035 DITITAL IVUS CATHETER is a medical device that received FDA 510(k) clearance on 2012-09-10. The listed applicant is Volcano Corporation. The 510(k) number is K121273.

When did VISIONS PV .035 DITITAL IVUS CATHETER receive FDA 510(k) clearance?

VISIONS PV .035 DITITAL IVUS CATHETER received FDA 510(k) clearance on 2012-09-10, under 510(k) number K121273.

Who is the listed applicant for VISIONS PV .035 DITITAL 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 VISIONS PV .035 DITITAL IVUS CATHETER?

The FDA product code for VISIONS PV .035 DITITAL IVUS CATHETER is OBJ.

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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.