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, peripheral, atherectomy
510(k) Number K133399
Device Name DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Applicant
CARDIOVASCULAR SYSTEMS INCORPORATED
651 CAMPUS DR.
SAINT PAUL,  MN  55112
Applicant Contact BLAIR BUTH
Correspondent
CARDIOVASCULAR SYSTEMS INCORPORATED
651 CAMPUS DR.
SAINT PAUL,  MN  55112
Correspondent Contact BLAIR BUTH
Regulation Number870.4875
Classification Product Code
MCW  
Date Received11/06/2013
Decision Date 11/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-