Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K153688
Device Name Edi Catheter ENFit
Applicant
MAQUET CRITICAL CARE AB
RONTGENVAGEN 2
SOLNA,  SE SE-171 54
Applicant Contact MIRVA BOOTHE
Correspondent
MAQUET MEDICAL SYSTEM USA
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact Mark Dinger
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
CBK  
Date Received12/23/2015
Decision Date 03/02/2017
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
Recalls CDRH Recalls
-
-