Cleared Special

K042611 - LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE

K042611 is an FDA 510(k) clearance for LUNDERQUIST EXTRA STIFF DOUBLE CURVED E..., manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 49-day FDA review.

K042611 · Cook, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 2004
Decision
49d
Days
Class 2
Risk

K042611 is an FDA 510(k) clearance for the LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 12, 2004 after a review of 49 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 Cook, Inc. devices

FDA 510(k) Submission Details - K042611

510(k) Number K042611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2004
Decision Date November 12, 2004
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 K042611.
TORAYGUIDE GUIDEWIRE
K042370 · Toray Industries (America), Inc. · Dec 2004
GUIDEWIRES
K042264 · Rocket Medical Plc · Nov 2004
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
K042996 · Volcano Therapeutics, Inc. · Nov 2004
SILICONE COATED GUIDEWIRE
K041740 · Arrow International, Inc. · Oct 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338 · Lake Region Mfg., Inc. · Sep 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K041973 · Intra Luminal Therapeutics, Inc. · Aug 2004