• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

  • 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 laser-powered inferior vena cava filter retrieval catheter
De Novo Number DEN210024
Device Name CavaClear Laser Sheath
Requester
Spectranetics, Inc.
9965 federal drive
colorado springs,  CO  80921
Contact sondra chandler
Regulation Number870.5125
Classification Product Code
QRJ  
Date Received06/25/2021
Decision Date 12/21/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
Type Direct
-
-