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 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K063723
FOIA Releasable 510(k) K063723
Device Name IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
Applicant
ABIOMED, INC.
22 CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact ROBERT T KUNG
Correspondent
ABIOMED, INC.
22 CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact ROBERT T KUNG
Regulation Number870.4360
Classification Product Code
KFM  
Subsequent Product Codes
DQO   DWF  
Date Received12/15/2006
Decision Date 05/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-