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 System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K950276
Device Name MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM
Applicant
Endosonics Corp.
3078-B Prospect Park Dr.
Rancho Cordova,  CA  95670
Applicant Contact ADAM D SAVAKUS
Correspondent
Endosonics Corp.
3078-B Prospect Park Dr.
Rancho Cordova,  CA  95670
Correspondent Contact ADAM D SAVAKUS
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received01/23/1995
Decision Date 09/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-