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 Suction Control, Intracardiac, Cardiopulmonary Bypass
510(k) Number K830150
Device Name VEINPREP VEIN GRAFT PREP. KIT A277723
Applicant
Atrium Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Atrium Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4430
Classification Product Code
DWD  
Date Received01/17/1983
Decision Date 02/28/1983
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
-
-