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 filter, blood, cardiopulmonary bypass, arterial line
510(k) Number K122760
Device Name AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
Applicant
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact JULIA A NELSON
Correspondent
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact JULIA A NELSON
Regulation Number870.4260
Classification Product Code
DTM  
Date Received09/10/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-