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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K203637
Device Name SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
Applicant
Coloplast
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Delaney McDougal
Correspondent
Coloplast
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact Delaney McDougal
Regulation Number876.5130
Classification Product Code
EZD  
Date Received12/14/2020
Decision Date 03/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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