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 Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K121402
Device Name CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G
Applicant
TRIREME MEDICAL, INC.
7060 Koll Center Parkway
Suite 300
Pleasanton,  CA  94566
Applicant Contact SHIVA ARDAKANI
Correspondent
TRIREME MEDICAL, INC.
7060 Koll Center Parkway
Suite 300
Pleasanton,  CA  94566
Correspondent Contact SHIVA ARDAKANI
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received05/10/2012
Decision Date 06/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-