• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K112565
Device Name NOVAPORT ONE VASCULAR ACCESS CANNULA
Original Applicant
NOVALUNG GMBH
3550 west liberty rd.
ann arbor,  MI  48103
Original Contact leann christman
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/02/2011
Decision Date 12/06/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-