FDA 510(k), K172567, GORE Molding and Occlusion Balloon Catheter
FDA 510(k), K172567, GORE Molding and Occlusion Balloon Catheter
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510(K) Number: K172567
Device Name: GORE Molding and Occlusion Balloon Catheter
Manufacturer: Jeremiah Andrews
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: 08/25/2017
Date Received: 01/31/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: GORE Molding and Occlusion Balloon Catheter
Manufacturer: Jeremiah Andrews
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: 08/25/2017
Date Received: 01/31/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- 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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