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, Nephrostomy
510(k) Number K845047
Device Name NEPHROSTOMY GUIDEWIRE SHEATH
Applicant
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711 -1150
Applicant Contact RONALD J EHMSEN
Correspondent
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711 -1150
Correspondent Contact RONALD J EHMSEN
Classification Product Code
LJE  
Date Received12/31/1984
Decision Date 01/15/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-