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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K153655
Device Name Accuryn Monitoring System
Applicant
POTRERO MEDICAL, INC.
101 MISSISSIPPI ST.
SAN FRANCISCO,  CA  94107
Applicant Contact DEVYANI NANDURI
Correspondent
POTRERO MEDICAL, INC.
101 MISSISSIPPI ST.
SAN FRANCISCO,  CA  94107
Correspondent Contact DEVYANI NANDURI
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Codes
EXY   PHU  
Date Received12/21/2015
Decision Date 04/15/2016
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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