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 Detector, Bubble, Cardiopulmonary Bypass
510(k) Number K090698
Device Name CAPIOX BUBBLE TRAP WITH X-COATING
Applicant
Terumo Cardiovascular Systems
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact GARRY A COURTNEY
Correspondent
Terumo Cardiovascular Systems
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact GARRY A COURTNEY
Regulation Number870.4205
Classification Product Code
KRL  
Date Received03/17/2009
Decision Date 06/08/2009
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
-
-