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 Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K943803
Device Name JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
Applicant
Janus Biomedical, Inc.
2525 Hartford Rd.
Austin,  TX  78703
Applicant Contact RICHARD MARTIN
Correspondent
Janus Biomedical, Inc.
2525 Hartford Rd.
Austin,  TX  78703
Correspondent Contact RICHARD MARTIN
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received08/04/1994
Decision Date 01/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-