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FDA 510(k), K173262, Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
FDA 510(k), K173262, Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
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510(K) Number: K173262
Device Name: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Manufacturer: Amy Stoklas-Oakes
Device Classification Name: Reprocessed Intravascular Ultrasound Catheter
Regulation Number: OWQ
Classification Product Code: KXA
Date Received: 10/11/2017
Decision Date: 03/06/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Manufacturer: Amy Stoklas-Oakes
Device Classification Name: Reprocessed Intravascular Ultrasound Catheter
Regulation Number: OWQ
Classification Product Code: KXA
Date Received: 10/11/2017
Decision Date: 03/06/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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