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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K193440
Device Name ER-REBOA PLUS Catheter
Applicant
Prytime Medical Devices, Inc.
229 N. Main St.
Boerne,  TX  78006
Applicant Contact Brian Young
Correspondent
Prytime Medical Devices, Inc.
229 N. Main St.
Boerne,  TX  78006
Correspondent Contact Brian Young
Regulation Number870.4450
Classification Product Code
MJN  
Subsequent Product Codes
DQO   DQY  
Date Received12/11/2019
Decision Date 01/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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