Cleared Special

K122795 - STINGRAY GUIDEWIRES

K122795 is an FDA 510(k) clearance for STINGRAY 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 57-day FDA review.

K122795 · Bridgepoint Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
57d
Days
Class 2
Risk

K122795 is an FDA 510(k) clearance for the STINGRAY 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 November 8, 2012 after a review of 57 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.

FDA 510(k) Submission Details - K122795

510(k) Number K122795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2012
Decision Date November 08, 2012
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 742
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K122795.
MERIT HYDROPHILIC GUIDE WIRE
K123609 · Merit Medical Systems, Inc. · Jan 2013
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
K121398 · Guidepath Medical, Inc. · Dec 2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573 · Abbott Vascular, Inc. · Nov 2012
TORQUE DEVICE
K123024 · Boston Scientific Corporation · Oct 2012
CHARTER GUIDEWIRE
K122856 · Brivant, Ltd. · Oct 2012
OSTIAL PRO STENT POSITIONING SYSTEM
K122089 · Merit Medical Systems, Inc. · Sep 2012
K122795 · STINGRAY GUIDEWIRES
Download PDF FDA Summary Bridgepoint Medical