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 K190604
Device Name PIVO
Applicant
Velano Vascular
221 Pine St. #200
San Francisco,  CA  94104
Applicant Contact Tiffini Wittwer
Correspondent
Velano Vascular
221 Pine St. #200
San Francisco,  CA  94104
Correspondent Contact Tiffini Wittwer
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/08/2019
Decision Date 05/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-