Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1

FDA 510(k) Premarket Notification · Submission K192019 · Applicant: ABBOTT MEDICAL

Public Record 510(k) Submission Decision Date: 2019-11-08 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K192019.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K192019
Applicant / Sponsor
Device Name
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
Product Code
DQO
Decision Date
2019-11-08
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Cardiovascular (CV)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2019-07-29

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.

Account Required Full available specs will require a free AvaSpecs account.