• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 West River Road North
Minneapolis,  MN  55411
Applicant Contact Delaney McDougal
Correspondent
Coloplast
1601 West River Road North
Minneapolis,  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
-
-