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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 K122916
Model PV41340 (CATHETER/POD); PVCN100 (PV CONSOLE)
Device Name JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
Applicant
MEDRAD, INC.
10801 120th avenue ne
kirkland,  WA  98033
Contact brit baird
Regulation Number870.4875
Classification Product Code
MCW  
Date Received09/21/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Clinical Trials NCT00676494
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-