Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
K-Number: K192019 · 2019-11-08
ApplicantABBOTT MEDICAL
Decision Date2019-11-08
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2019-11-08 under approval number K192019. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1?
Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K192019.
When was Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 approved by the FDA?
Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 received FDA 510(k) clearance on 2019-11-08, under approval number K192019.
What company makes Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1?
Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 is manufactured by ABBOTT MEDICAL.
What is the FDA product code for Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1?
The FDA product code for Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 is DQO.
Related Clinical Trials
NCT07615972
Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis
NOT_YET_RECRUITING
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT02193425
Reliability of the Human Brain Connectome
COMPLETED
NCT02710916
SD-OCT Multimodal Analysis in GLaucoma
COMPLETED
NCT07385508
Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches
RECRUITING
NCT03053141
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
RECRUITING
Related PubMed Literature
PMID: 41938602
AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance.
Frontiers in digital health (2026)
PMID: 41883556
A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software.
Digital health (2026)
PMID: 41476571
Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report.
Journal of pathology informatics (2026)
PMID: 41116086
Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD).
GeroScience (2025)
Other Devices by ABBOTT MEDICAL
K192267ILUMIEN System with AptiVue Software version D.3
K192037Advisor VL Circular Mapping Catheter, Sensor Enabled
K190581Amplatzer Trevisio Intravascular Delivery System
K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
K201610IonicRF Generator
K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
Related Devices (Code: DQO)
K161822Torcon NB Advantage CathetersCook Incorporated
K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-PakMedtronic Vascular
K160662Surefire Infusion SystemSurefire Medical, Inc.
K153125IntraNovo MicrocatheterTexasmedical Technologies, Inc.
K170544Langston dual lumen catheterVascular Solutions, Inc.
K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing CatheterCook Incorporated
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.