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 K951720
Device Name SCIMED EXPO ANGIOGRAPHIC CATHETER
Applicant
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact DEBORAH L JENSEN
Correspondent
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact DEBORAH L JENSEN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/14/1995
Decision Date 06/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-