Cleared Traditional

K161287 - DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak

K161287 is an FDA 510(k) clearance for DxTerity, manufactured by Medtronic Vascular. 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.

K161287 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
102d
Days
Class 2
Risk

K161287 is an FDA 510(k) clearance for the DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Ang.... Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on August 19, 2016 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K161287

510(k) Number K161287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 09, 2016
Decision Date August 19, 2016
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 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K161287.
Medline Waste Station
K160660 · Medline Industries, Inc. · Jan 2017
NAMIC ClearaCIL Contrast Injection Lines
K163141 · AngioDynamics, Inc. · Jan 2017
Torcon NB Advantage Catheters
K161822 · Cook Incorporated · Oct 2016
Surefire Infusion System
K160662 · Surefire Medical, Inc. · Mar 2016
IntraNovo Microcatheter
K153125 · Texasmedical Technologies, Inc. · Jan 2016
Foresight Intracardiac Echocardiography (ICE) System
K151126 · Colibri Technologies, Inc. · Dec 2015