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 Echocardiograph
510(k) Number K901562
Device Name CVIS INSIGHT IMAGING CATHETER
Applicant
CARDIOVASCULAR IMAGING SYSTEMS, INC.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085
Applicant Contact RUSSELL W FELKEY
Correspondent
CARDIOVASCULAR IMAGING SYSTEMS, INC.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085
Correspondent Contact RUSSELL W FELKEY
Regulation Number870.2330
Classification Product Code
DXK  
Date Received04/03/1990
Decision Date 07/09/1990
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
-
-