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 For Crossing Total Occlusions
510(k) Number K071227
Device Name CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15
Applicant
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907 -5159
Applicant Contact MICHAEL K HANDLEY
Correspondent
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907 -5159
Correspondent Contact MICHAEL K HANDLEY
Regulation Number870.1250
Classification Product Code
PDU  
Date Received05/03/2007
Decision Date 07/11/2007
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
Recalls CDRH Recalls
-
-