Cleared Traditional

SPEX SUPPORT CATHETER (K141649) - FDA 510(k) Clearance

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

K141649 · Reflow Medical · Cardiovascular device
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Nov 2014
Decision
138d
Days
Class 2
Risk

K141649 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 (San Clemente, US). The FDA issued a Cleared decision on November 5, 2014 after a review of 138 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K141649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2014
Decision Date November 05, 2014
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 324
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K141649.
YOGA Microcatheter
K162563 · Codman & Shurtleff, Inc. · Jan 2017
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015
Coda LP Balloon Catheter
K150970 · Cook Incorporated · May 2015
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
K140080 · Codman & Shurtleff, Inc. · Apr 2014
ENVOY GUIDING CATHETER
K140307 · Codman & Shurtleff, Inc. · Apr 2014
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014