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 K200499
Device Name QuickDraw Venous Cannula
Applicant
Edwards Lifesciences LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Diem My Nguyen
Correspondent
Edwards Lifesciences LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Diem My Nguyen
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/28/2020
Decision Date 03/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-