Cleared Traditional

K141649 - SPEX SUPPORT CATHETER

K141649 is an FDA 510(k) clearance for SPEX SUPPORT CATHETER, manufactured by Reflow Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K141649

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.

DQY Device Classification - Class 2, Special Controls

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 622
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K141649.
CPS Direct MediGuide Enabled outer catheter
K142239 · St Jude Medical · Dec 2014
TURNPIKE CATHETER
K142065 · Vascular Solutions, Inc. · Nov 2014
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter
K142565 · Stryker Neurovascular · Nov 2014
SOFIA DISTAL ACCESS CATHETER
K142014 · MicroVention, Inc. · Oct 2014
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