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 K172264
Device Name OTW Takeru PTCA Balloon Dilatation Catheter
Applicant
KANEKA Corporation
1-12-32, Akasaka, Minato-Ku
Tokyo,  JP 107-6028
Applicant Contact Toshihiko Motomine
Correspondent
Quintilesims
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact Christopher M. Sloan
Regulation Number870.5100
Classification Product Code
LOX  
Date Received07/27/2017
Decision Date 03/19/2018
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
-
-