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 Mechanical Thrombolysis Catheter
510(k) Number K071933
Device Name ENDOWAVE INFUSION SYSTEM
Applicant
Ekos Corp.
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Applicant Contact JOCELYN KERSTEN
Correspondent
Ekos Corp.
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received07/13/2007
Decision Date 08/10/2007
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
-
-