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 K020784
Device Name JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
Applicant
JOSTRA AG
P.O. BOX 218
OXFORD,  PA  19363
Applicant Contact KATHLEEN JOHNSON
Correspondent
JOSTRA AG
P.O. BOX 218
OXFORD,  PA  19363
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/11/2002
Decision Date 01/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-