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 K153213
Device Name Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
Applicant
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact Tierra A Brown
Correspondent
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact Tierra A Brown
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTN   DTP   DTR  
Date Received11/05/2015
Decision Date 12/03/2015
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
-
-