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FDA 510(k), K171534, SurgicalPreview
FDA 510(k), K171534, SurgicalPreview
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510(K) Number: K171534
Device Name: SurgicalPreview
Manufacturer: Endo Vantage, LLC
Device Classification Name: software for visualization of vascular anatomy and intravascular devices
Regulation Number: 892.2050
Classification Product Code: PZO
Date Received: 05/25/2017
Decision Date: 11/08/2017
Regulation Medical Specialty: Radiology
Device Name: SurgicalPreview
Manufacturer: Endo Vantage, LLC
Device Classification Name: software for visualization of vascular anatomy and intravascular devices
Regulation Number: 892.2050
Classification Product Code: PZO
Date Received: 05/25/2017
Decision Date: 11/08/2017
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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