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 set, administration, intravascular
510(k) Number K970485
Device Name SMARTSITE ACCESS PIN
Applicant
IVAC MEDICAL SYSTEMS
10221 WATERIDGE CIRCLE
SAN DIEGO,  CA  92121
Applicant Contact RENEE L FLUET
Correspondent
IVAC MEDICAL SYSTEMS
10221 WATERIDGE CIRCLE
SAN DIEGO,  CA  92121
Correspondent Contact RENEE L FLUET
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/10/1997
Decision Date 04/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-