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FDA 510(k), K173860, s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
FDA 510(k), K173860, s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
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510(K) Number: K173860
Device Name: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
Manufacturer: Volcano Corporation
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 12/20/2017
Decision Date: 04/11/2018
Regulation Medical Specialty: Radiology
Device Name: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
Manufacturer: Volcano Corporation
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 12/20/2017
Decision Date: 04/11/2018
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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