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 Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K022857
Device Name PUMP TUBING WITH X-COATING
Applicant
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact KAZUHITO INOUE
Correspondent
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact KAZUHITO INOUE
Regulation Number870.4390
Classification Product Code
DWE  
Date Received08/28/2002
Decision Date 09/19/2002
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
-
-