Cleared Special

Maestro Microcatheter (K172081) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172081 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
25d
Days
Class 2
Risk

K172081 is an FDA 510(k) clearance for the Maestro Microcatheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 4, 2017 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K172081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2017
Decision Date August 04, 2017
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 75
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K172081.
VAMP Venous/Arterial Blood Management Protection System
K173586 · Edwards Lifesciences, LLC · Apr 2018
Microcatheter and guide-wire system
K171665 · Suzhou Hengrui Disheng Medical Co., Ltd. · Jan 2018
CXI TriForce Peripheral Crossing Set
K170931 · Cook Incorporated · Nov 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · Boston Scientific Corporation · May 2017
VAMP Venous/Arterial Blood Management Protection System
K161962 · Edwards Lifesciences, LLC · Nov 2016
CXI Support Catheter
K160884 · Cook Incorporated · Nov 2016