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 Catheter, Intravascular, Diagnostic
510(k) Number K921879
Device Name CBIS CATHETER PULL-BACK DEVICE
Applicant
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact STAN E TILLMAN
Correspondent
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact STAN E TILLMAN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/20/1992
Decision Date 07/16/1992
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
-
-