Cleared Special

K121745 - MANTARAY GUIDEWIRES

K121745 is an FDA 510(k) clearance for MANTARAY GUIDEWIRES, manufactured by Bridgepoint Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 29-day FDA review.

K121745 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
29d
Days
Class 2
Risk

K121745 is an FDA 510(k) clearance for the MANTARAY GUIDEWIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Bridgepoint Medical (Plymouth, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 29 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K121745

510(k) Number K121745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2012
Decision Date July 13, 2012
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
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 607
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K121745.
OSTIAL PRO STENT POSITIONING SYSTEM
K122089 · Merit Medical Systems, Inc. · Sep 2012
MERIT HYDROPHILIC GUIDE WIRE
K120644 · Merit Medical Systems, Inc. · Sep 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · Codman & Shurtleff, Inc. · Aug 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · Covidien, LLC · Apr 2012
14 WIRE STANDARD, 14 WIRE LS
K113454 · Micro Therapeutics, Inc. · Feb 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
K113716 · Asahi Intecc Co., Ltd. · Feb 2012