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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K052570
Device Name TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
Applicant
Cardiacassist, Inc.
240 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact TIM KRAUSKOPF
Correspondent
Cardiacassist, Inc.
240 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact TIM KRAUSKOPF
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/19/2005
Decision Date 01/17/2006
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
Recalls CDRH Recalls
-
-