• 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, intravascular, diagnostic
510(k) Number K192019
Device Name Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Applicant Contact Richard DeMello
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Correspondent Contact Richard DeMello
Regulation Number870.1200
Classification Product Code
Subsequent Product Code
Date Received07/29/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls