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, Percutaneous, Cutting/Scoring
510(k) Number K151253
Device Name 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
Applicant
Boston Scientific Limited
Ballybrit Business Park
Galway,  IE
Applicant Contact LISA MEE
Correspondent
Boston Scientific Limited
Ballybrit Business Park
Galway,  IE
Correspondent Contact LISA MEE
Regulation Number870.1250
Classification Product Code
PNO  
Date Received05/12/2015
Decision Date 06/10/2015
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
-
-