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 K112771
Device Name BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
Applicant
Sorin Group Italia S.R.L.
14401 W. 65th Way
Arvada,  CO  80004
Applicant Contact SCOTT LIGHT
Correspondent
Sorin Group Italia S.R.L.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact SCOTT LIGHT
Regulation Number870.4400
Classification Product Code
DTN  
Date Received09/23/2011
Decision Date 10/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-