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 K041630
Device Name ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Applicant
Cardiovascular Systems Incorporated
800 Levanger Ln.
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Cardiovascular Systems Incorporated
800 Levanger Ln.
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number870.4875
Classification Product Code
MCW  
Date Received06/16/2004
Decision Date 01/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-