Cleared Special

K061670 - LUNDERQUIST WIRE GUIDE

Also marketed or referenced as:
DC WIRE GUIDE

K061670 is an FDA 510(k) clearance for LUNDERQUIST WIRE GUIDE, manufactured by William Cook Europe Aps. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 219-day FDA review.

K061670 · William Cook Europe Aps · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
219d
Days
Class 2
Risk

K061670 is an FDA 510(k) clearance for the LUNDERQUIST WIRE GUIDE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on January 19, 2007 after a review of 219 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all William Cook Europe Aps devices

FDA 510(k) Submission Details - K061670

510(k) Number K061670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2006
Decision Date January 19, 2007
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 542
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K061670.
RUNTHROUGH NS
K063695 · Terumo Medical Corp. · Apr 2007
COOK MICROWIRE WIRE GUIDE
K070410 · Cook, Inc. · Apr 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819 · Asahi Intecc Co., Ltd. · Jan 2007
RADIFOCUS GLIDEWIRE ADVANTAGE
K063372 · Terumo Medical Corp. · Jan 2007
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
K062186 · Asahi Intecc Co., Ltd. · Nov 2006
TREASURE
K061984 · Asahi Intecc Co., Ltd. · Oct 2006