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 K955121
Device Name HEARTPORT ENDOARTERIAL RETURN CANNUAL
Applicant
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Applicant Contact DAVID A TUCKER
Correspondent
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Correspondent Contact DAVID A TUCKER
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/09/1995
Decision Date 05/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-