• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K112381
Model 1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594, 1012595
Device Name HI TORQUE CONNECT GUIDEWIRE
Original Applicant
LAKE REGION MEDICAL
lake region med intl r&d ctr
parkmore west business
galway,  EI ei
Original Contact kenny walsh
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/17/2011
Decision Date 11/03/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-