Cleared Special

K083727 - STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012

K083727 is an FDA 510(k) clearance for STINGRAY GUIDEWIRE, 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 67-day FDA review.

K083727 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
67d
Days
Class 2
Risk

K083727 is an FDA 510(k) clearance for the STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012. 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 February 20, 2009 after a review of 67 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 - K083727

510(k) Number K083727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date February 20, 2009
Days to Decision 67 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
58d faster than avg
Panel avg: 125d · This submission: 67d
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 K083727.
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
K090274 · Micrus Endovascular Corporation · Mar 2009
TAD AND TAD II TAPERED GUIDE WIRES
K083732 · Abbott Vascular · Feb 2009
.035 LOC GUIDE WIRE EXTENSION
K083713 · Abbott Vascular · Feb 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873 · Medtronic Vascular · Feb 2009
HI-TORQUE VERSACORE GUIDE WIRE
K083706 · Abbott Vascular · Feb 2009
ASAHI SUOH PTCA GUIDE WIRE
K083904 · Asahi Intecc Co., Ltd. · Jan 2009