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 apparatus, autotransfusion
510(k) Number K984233
Device Name C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
Applicant
FRESENIUS HEMOTECHNOLOGY, INC.
110 MASON CIRCLE SUITE A
CONCORD,  CA  94520 -1238
Applicant Contact VIRGINIA R SINGER
Correspondent
FRESENIUS HEMOTECHNOLOGY, INC.
110 MASON CIRCLE SUITE A
CONCORD,  CA  94520 -1238
Correspondent Contact VIRGINIA R SINGER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/25/1998
Decision Date 02/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-