Cleared Traditional

K200317 - Support Catheter

K200317 is the FDA 510(k) clearance for Support Catheter by Qxmedical, LLC. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K200317 · Qxmedical, LLC · Cardiovascular device
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May 2020
Decision
97d
Days
Class 2
Risk

K200317 is an FDA 510(k) clearance for the Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Qxmedical, LLC (Saint Paul, US). The FDA issued a Cleared decision on May 14, 2020 after a review of 97 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 Qxmedical, LLC devices

Submission Details

510(k) Number K200317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2020
Decision Date May 14, 2020
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K200317.
Twin-Pass Dual Access Catheter
K193119 · Vascular Solutions, LLC · Jun 2020
Benchmark BMX96 Access System
K201271 · Penumbra, Inc. · Jun 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721 · Abbott (St. Jude Medical) · Jun 2020
XO Cross Support Catheter
K193420 · Transit Scientific · May 2020
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