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 Timer, Clot, Automated
510(k) Number K953870
Device Name ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
Applicant
Medtronic Vascular
18501 E Plz. Dr.
Parker,  CO  80134
Applicant Contact JAMES M LUMPKIN
Correspondent
Medtronic Vascular
18501 E Plz. Dr.
Parker,  CO  80134
Correspondent Contact JAMES M LUMPKIN
Regulation Number864.5400
Classification Product Code
GKN  
Date Received08/17/1995
Decision Date 10/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-