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

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