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 catheter, continuous flush
510(k) Number K924661
Device Name SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Applicant Contact FOSS DAVIES
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Correspondent Contact FOSS DAVIES
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/15/1992
Decision Date 04/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-