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, Embolectomy
510(k) Number K961716
Device Name VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
Applicant
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Applicant Contact ELIZABETH M PAUL
Correspondent
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Correspondent Contact ELIZABETH M PAUL
Regulation Number870.5150
Classification Product Code
DXE  
Date Received05/02/1996
Decision Date 09/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-