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 Stylet, Catheter
510(k) Number K142116
Device Name LLD EZ
Applicant
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact PHAROAH GARMA
Correspondent
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact PHAROAH GARMA
Regulation Number870.1380
Classification Product Code
DRB  
Date Received08/04/2014
Decision Date 08/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-