Cleared Traditional

Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (K193596) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K193596 · Reflow Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
59d
Days
Class 2
Risk

K193596 is an FDA 510(k) clearance for the Wingman 14, Wingman 14C, Wingman 18, Wingman 35. 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 February 20, 2020 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reflow Medical devices

Submission Details

510(k) Number K193596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date February 20, 2020
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03403426 Completed Interventional Industry-sponsored

ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries

85
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Chronic Total Occlusion of Artery of the Extremities
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator John Laird, MD
Sponsor ReFlow Medical, Inc. (industry)
Started 2018-02-13 → Primary completion 2019-08-08
Primary outcome
Number of Lesions With Successful CTO Crossing Assessed by Angiography
Secondary outcome
Lesion Success
View full study on ClinicalTrials.gov

Regulatory Peers - DQY Catheter, Percutaneous

All 324
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K193596.
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
K192558 · Mivi Neurovascular · Apr 2020
NovaCross CTO Microcatheter
K193322 · Nitiloop , Ltd. · Apr 2020
speX LP Support Catheter
K200094 · Reflow Medical · Mar 2020
speX Support Catheter
K193012 · Reflow Medical · Feb 2020
TrapIt
K191229 · Imds Operations B.V. · Jan 2020
Route 92 Medical Sheath System
K191717 · Route 92 Medical, Inc. · Jan 2020