• 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 angioscope
510(k) Number K923996
Device Name DISPOSABLE VASCULAR ANGIOSCOPE
Applicant
ENDOVASCULAR, INC.
3180 PULLMAN ST.
costa mesa,  CA  92626
Applicant Contact karen u salinas
Correspondent
ENDOVASCULAR, INC.
3180 PULLMAN ST.
costa mesa,  CA  92626
Correspondent Contact karen u salinas
Regulation Number876.1500
Classification Product Code
LYK  
Date Received08/10/1992
Decision Date 01/13/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-