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 K081467
Device Name EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
Applicant
EKOS CORP.
11911 N CREEK PARKWAY SOUTH
BOTHELL,  WA  98011
Applicant Contact JOCELYN KERSTEN
Correspondent
EKOS CORP.
11911 N CREEK PARKWAY SOUTH
BOTHELL,  WA  98011
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received05/27/2008
Decision Date 06/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-