Cleared Traditional

K192019 - Dragonfly OpStar Imaging Catheter

K192019 is an FDA 510(k) clearance for Dragonfly OpStar Imaging Catheter, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K192019

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.

DQO Device Classification - Class 2, Special Controls

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 319
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