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FDA 510(k), K161700, SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
FDA 510(k), K161700, SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
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$149.00 USD
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$149.00 USD
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510(K) Number: K161700
Device Name: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
Manufacturer: STERILMED, INC.
Device Classification Name: reprocessed intravascular ultrasound catheter
Regulation Number: 870.1200
Classification Product Code: OWQ
Date Received: 06/20/2016
Decision Date: 11/21/2016
Regulation Medical Specialty: Cardiovascular
Device Name: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
Manufacturer: STERILMED, INC.
Device Classification Name: reprocessed intravascular ultrasound catheter
Regulation Number: 870.1200
Classification Product Code: OWQ
Date Received: 06/20/2016
Decision Date: 11/21/2016
Regulation Medical Specialty: Cardiovascular
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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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