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 sleeve, limb, compressible
510(k) Number K911853
Device Name PULSATILE ANTI-EMBOLISM SYS.PUMP
Applicant
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Applicant Contact ROBERT T.MERRICK
Correspondent
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Correspondent Contact ROBERT T.MERRICK
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/26/1991
Decision Date 07/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-