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 Probe, Blood-Flow, Extravascular
510(k) Number K012747
Device Name TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
Applicant
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Applicant Contact MARIE HOLM
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Correspondent Contact MARIE HOLM
Regulation Number870.2120
Classification Product Code
DPT  
Date Received08/16/2001
Decision Date 09/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-