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 K162625
Device Name SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
Applicant
B. Braun Interventional Systems, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact PETER FLOSDORF
Correspondent
B. Braun Interventional Systems, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact PETER FLOSDORF
Regulation Number870.5100
Classification Product Code
LOX  
Date Received09/20/2016
Decision Date 06/12/2017
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
-
-