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 Oxygenator, Cardiopulmonary Bypass
510(k) Number K102464
Device Name QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
Applicant
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Applicant Contact KATRIN SCHWENKGLENKS
Correspondent
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Correspondent Contact KATRIN SCHWENKGLENKS
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTR  
Date Received08/27/2010
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-