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FDA 510(k), K182238, Reprocessed ViewFlex Xtra ICE Catheter
FDA 510(k), K182238, Reprocessed ViewFlex Xtra ICE Catheter
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$149.00 USD
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510(K) Number: K182238
Device Name: Reprocessed ViewFlex Xtra ICE Catheter
Manufacturer: Ramona Kulik
Device Classification Name: Reprocessed Intravascular Ultrasound Catheter
Regulation Number: OWQ
Classification Product Code: 08/20/2018
Date Received: 05/08/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Reprocessed ViewFlex Xtra ICE Catheter
Manufacturer: Ramona Kulik
Device Classification Name: Reprocessed Intravascular Ultrasound Catheter
Regulation Number: OWQ
Classification Product Code: 08/20/2018
Date Received: 05/08/2019
Decision Date: Substantially Equivalent (SESE)
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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