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 Clamp, Vascular
510(k) Number K070485
Device Name BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L
Applicant
Cardiva Medical, Inc.
155 Moffett Park Dr.,
Suite A-101
Sunnyvale,  CA  94089
Applicant Contact MICHAEL J BILLIG
Correspondent
Cardiva Medical, Inc.
155 Moffett Park Dr.,
Suite A-101
Sunnyvale,  CA  94089
Correspondent Contact MICHAEL J BILLIG
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/20/2007
Decision Date 03/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-