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 Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K142946
Device Name TIVA
Applicant
Velano Vascular, Inc.
1500 Locust St. Suite 4311
Philadelphia,  PA  19102
Applicant Contact Tiffini Diage
Correspondent
Velano Vascular, Inc.
1500 Locust St. Suite 4311
Philadelphia,  PA  19102
Correspondent Contact Tiffini Diage
Regulation Number862.1675
Classification Product Code
JKA  
Date Received10/10/2014
Decision Date 01/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-