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 Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K012942
Device Name THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
Applicant
CIRCULATORY TECHNOLOGY, INC.
21 SINGWORTH ST.
OYSTER BAY,  NY  11771
Applicant Contact YEHUDA TAMARI
Correspondent
CIRCULATORY TECHNOLOGY, INC.
21 SINGWORTH ST.
OYSTER BAY,  NY  11771
Correspondent Contact YEHUDA TAMARI
Regulation Number870.4400
Classification Product Code
DTN  
Date Received08/31/2001
Decision Date 11/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-