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 Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K111544
Device Name GLIDER PTCA BALLOON CATHETER
Applicant
Trireme Medical, Inc.
7060 Knoll Center Pkwy.
Suite 300
Pleasanton,  CA  94566
Applicant Contact SHIVA ARDAKANI
Correspondent
Trireme Medical, Inc.
7060 Knoll Center Pkwy.
Suite 300
Pleasanton,  CA  94566
Correspondent Contact SHIVA ARDAKANI
Regulation Number870.5100
Classification Product Code
LOX  
Date Received06/03/2011
Decision Date 03/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-