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 Catheter, Percutaneous
510(k) Number K070126
Device Name OCCLUSION BALLOON CATHETER
Applicant
SENTREHEART INC.
2468 EMBARCADERO WAY
PALO ALTO,  CA  94303
Applicant Contact LINDA GUTHRIE
Correspondent
SENTREHEART INC.
2468 EMBARCADERO WAY
PALO ALTO,  CA  94303
Correspondent Contact LINDA GUTHRIE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/16/2007
Decision Date 02/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-