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 Wire, Guide, Catheter
510(k) Number K101011
Device Name HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
Applicant
Abbott Vascular, Inc.
26531 Ynez Rd.
Temecula,  CA  92589
Applicant Contact KAY SETZER
Correspondent
Abbott Vascular, Inc.
26531 Ynez Rd.
Temecula,  CA  92589
Correspondent Contact KAY SETZER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/12/2010
Decision Date 05/24/2010
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
-
-