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 K150267
Device Name QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
Applicant
MAQUET CARDIOPULMONARY AG
KEHLER STRASSE 31
RASTATT,  DE 76437
Applicant Contact Whitney Torning
Correspondent
MAQUET Cardiovascular
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact Whitney Torning
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received02/04/2015
Decision Date 05/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-