Cleared Traditional

K160561 - Boosting Catheter

K160561 is the FDA 510(k) clearance for Boosting Catheter by Qxmedical, LLC. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K160561 · Qxmedical, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
247d
Days
Class 2
Risk

K160561 is an FDA 510(k) clearance for the Boosting 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 November 2, 2016 after a review of 247 days - an extended review 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: 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 K160561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date November 02, 2016
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
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 574
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K160561.
TrapLiner catheter
K161901 · Vascular Solutions, Inc. · Feb 2017
Twin-Pass Torque
K162467 · Vascular Solutions, Inc. · Feb 2017
YOGA Microcatheter
K162563 · Codman & Shurtleff, Inc. · Jan 2017
ASAHI Corsair Pro
K161126 · Asahi Intecc Co., Ltd. · Aug 2016
ASAHI Corsair Armet
K161362 · Asahi Intecc Co., Ltd. · Jun 2016
ASAHI Corsair Armet
K152249 · Asahi Intecc Co., Ltd. · Mar 2016