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 K180694
Device Name Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Applicant
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Travis Pittman
Correspondent
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Travis Pittman
Regulation Number870.4875
Classification Product Code
MCW  
Date Received03/16/2018
Decision Date 04/05/2018
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
-
-