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FDA 510(k)

KODAMA INTRAVASCULAR ULRASOUND CATHETER

K-Number: K113008 · 2012-06-14

ApplicantSilicon Vally Medical Instruments, Inc.
Decision Date2012-06-14
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KODAMA INTRAVASCULAR ULRASOUND CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Silicon Vally Medical Instruments, Inc.. It received FDA 510(k) clearance on 2012-06-14 under 510(k) number K113008. 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 KODAMA INTRAVASCULAR ULRASOUND CATHETER?

KODAMA INTRAVASCULAR ULRASOUND CATHETER is a medical device that received FDA 510(k) clearance on 2012-06-14. The listed applicant is Silicon Vally Medical Instruments, Inc.. The 510(k) number is K113008.

When did KODAMA INTRAVASCULAR ULRASOUND CATHETER receive FDA 510(k) clearance?

KODAMA INTRAVASCULAR ULRASOUND CATHETER received FDA 510(k) clearance on 2012-06-14, under 510(k) number K113008.

Who is the listed applicant for KODAMA INTRAVASCULAR ULRASOUND CATHETER?

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

What is the FDA product code for KODAMA INTRAVASCULAR ULRASOUND CATHETER?

The FDA product code for KODAMA INTRAVASCULAR ULRASOUND CATHETER is OBJ.

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Other records listing Silicon Vally Medical Instruments, Inc. as applicant

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.

K122878HD-IVUS ULTRASOUND IMAGING SYSTEMK112997HD-IVUS ULTRASOUND IMAGING SYSTEM

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

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

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