Cleared Traditional

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192019 · Abbott Medical · Cardiovascular device
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Nov 2019
Decision
102d
Days
Class 2
Risk

K192019 is an FDA 510(k) clearance for the Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Abbott Medical (Westford, US). The FDA issued a Cleared decision on November 8, 2019 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Medical devices

Submission Details

510(k) Number K192019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date November 08, 2019
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 155
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K192019.
Superpipe Angiographic Catheter
K193647 · Suzhou Hengrui Disheng Medical Co., Ltd. · Jul 2020
ILUMIEN System with AptiVue Software version D.3
K192267 · Abbott Medical · Dec 2019
Trevo Trak 21 Microcatheter
K192122 · Stryker · Nov 2019
Bendit2.7 Steerable Microcatheter
K190126 · Bend IT Technologies, Ltd. · Aug 2019
Impress Angiographic Catheter
K191608 · Merit Medical Systems, Inc. · Jul 2019
Polyethylene Catheter
K181722 · Cook Incorporated · Mar 2019