K-number	K151821
Device name	ER-REBOA Catheter
Applicant	Pryor Medical Devices, Inc.
Product code	DQY
Device class	Class II
Decision date	Oct 23, 2015
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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ER-REBOA Catheter

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