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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name catheter, intravascular, diagnostic
510(K) Number K842195
Device Name ADVANCED CARDIOVASCULAR-CORONARY GUID
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 lakeside dr.
santa clara,  CA  95054 2807
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/04/1984
Decision Date 07/13/1984
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-