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 oxygenator, cardiopulmonary bypass
510(k) Number K894970
Device Name WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
Applicant
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact LEROY J FISCHBACH
Correspondent
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact LEROY J FISCHBACH
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received08/07/1989
Decision Date 11/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-