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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 K170411
Device Name ER-REBOA Catheter
Applicant
Prytime Medical Devices, Inc
229 North Main Street
boerne,  TX  78006
Applicant Contact brian young
Correspondent
Prytime Medical Devices, Inc
229 North Main Street
boerne,  TX  78006
Correspondent Contact brian young
Regulation Number870.4450
Classification Product Code
MJN  
Subsequent Product Codes
DQO   DQY  
Date Received02/10/2017
Decision Date 04/04/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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