• 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 K002273
Device Name STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
Applicant
Stoeckert Instrumente
14401 W. 65th Way
Arvada,  CO  80004
Applicant Contact BARBARA WATSON
Correspondent
Stoeckert Instrumente
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact BARBARA WATSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/26/2000
Decision Date 01/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-