Cleared Special

speX Support Catheter (K173662) - FDA 510(k) Clearance

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

K173662 · Reflow Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 2017
Decision
21d
Days
Class 2
Risk

K173662 is an FDA 510(k) clearance for the speX Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Reflow Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on December 20, 2017 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Reflow Medical, Inc. devices

Submission Details

510(k) Number K173662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2017
Decision Date December 20, 2017
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 319
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K173662.
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709 · Inneuroco, Inc. · Jan 2018
Microcatheter
K173560 · Surmodics,Inc. · Jan 2018
Attain Assist CS Access Catheter
K171819 · Creganna Medical Also Doing Business AS Ceganna Tactx Medica · Jan 2018
GuideLiner V3 Catheter
K172090 · Vascular Solutions, Inc. · Oct 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · Boston Scientific Corporation · Aug 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · Boston Scientific Corporation · Jul 2017