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 Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K871131
Device Name SARNS 9000 HEART-LUNG CONSOLE
Applicant
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact JOSEPH W O'DONNELL
Correspondent
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact JOSEPH W O'DONNELL
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received03/20/1987
Decision Date 05/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-