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 Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K141432
Device Name NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
Applicant
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Applicant Contact KATRIN SCHWENKGLENKS
Correspondent
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Correspondent Contact KATRIN SCHWENKGLENKS
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Code
DTP  
Date Received05/30/2014
Decision Date 07/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-