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FDA 510(k), K113008, KODAMA INTRAVASCULAR ULRASOUND CATHETER
FDA 510(k), K113008, KODAMA INTRAVASCULAR ULRASOUND CATHETER
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510(K) Number: K113008
Device Name: KODAMA INTRAVASCULAR ULRASOUND CATHETER
Manufacturer: SILICON VALLY MEDICAL INSTRUMENTS, INC.
Device Classification Name: catheter, ultrasound, intravascular
Regulation Number: 870.1200
Classification Product Code: OBJ
Date Received: 10/07/2011
Decision Date: 06/14/2012
Regulation Medical Specialty: Cardiovascular
Device Name: KODAMA INTRAVASCULAR ULRASOUND CATHETER
Manufacturer: SILICON VALLY MEDICAL INSTRUMENTS, INC.
Device Classification Name: catheter, ultrasound, intravascular
Regulation Number: 870.1200
Classification Product Code: OBJ
Date Received: 10/07/2011
Decision Date: 06/14/2012
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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