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 K083111
Device Name IMPELLA 5.0 CATHETER FAMILY
Applicant
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact WILLIAM BOLT
Correspondent
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact WILLIAM BOLT
Regulation Number870.4360
Classification Product Code
KFM  
Date Received10/21/2008
Decision Date 04/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00534859
NCT00596726
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-