Cleared Special

Surefire Guiding Catheter (K162359) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162359 · Surefire Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
29d
Days
Class 2
Risk

K162359 is an FDA 510(k) clearance for the Surefire Guiding Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Surefire Medical, Inc. (Westminster, US). The FDA issued a Cleared decision on September 21, 2016 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Surefire Medical, Inc. devices

Submission Details

510(k) Number K162359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date September 21, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 391
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K162359.
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
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015
Coda LP Balloon Catheter
K150970 · Cook Incorporated · May 2015
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
K142235 · St Jude Medical · Dec 2014