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 Injector And Syringe, Angiographic
510(k) Number K040298
Device Name ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
Applicant
Acist Medical Systems, Inc.
7450 Flying Clouds Dr.
Suite 150
Eden Prairie,  MN  55344
Applicant Contact CARL M BEAURLINE
Correspondent
Acist Medical Systems, Inc.
7450 Flying Clouds Dr.
Suite 150
Eden Prairie,  MN  55344
Correspondent Contact CARL M BEAURLINE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/09/2004
Decision Date 03/15/2004
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
Recalls CDRH Recalls
-
-