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 transducer, pressure, catheter tip
510(k) Number K910429
Device Name SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Applicant Contact TIM R WILLIAMS
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Correspondent Contact TIM R WILLIAMS
Regulation Number870.2870
Classification Product Code
DXO  
Date Received02/01/1991
Decision Date 07/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-