Cleared Special

K151244 - Pre-Formed Guidewire

K151244 is an FDA 510(k) clearance for Pre-Formed Guidewire, manufactured by Lake Region Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 31-day FDA review.

K151244 · Lake Region Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
31d
Days
Class 2
Risk

K151244 is an FDA 510(k) clearance for the Pre-Formed Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on June 11, 2015 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Lake Region Medical devices

FDA 510(k) Submission Details - K151244

510(k) Number K151244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2015
Decision Date June 11, 2015
Days to Decision 31 days
Submission Type Special
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
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K151244.
Medtronic Confida Brecker Guidewire
K150465 · Medtronic Core Valve, LLC · Aug 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · Asahi Intecc Co., Ltd. · Jun 2015
Opto Wire and OptoMonitor System
K142598 · Opsens, Inc. · Jun 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · Cook Incorporated · May 2015
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
K143252 · Needle Tech Products, Inc. · Apr 2015
Attain Hybrid Guide Wire
K143316 · Medtronic, Inc. · Mar 2015