Cleared Special

K000011 - MODIFIED HYDROPHILIC COATED GUIDEWIRE

K000011 is an FDA 510(k) clearance for MODIFIED HYDROPHILIC COATED GUIDEWIRE, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 58-day FDA review.

K000011 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
58d
Days
Class 2
Risk

K000011 is an FDA 510(k) clearance for the MODIFIED HYDROPHILIC COATED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 58 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K000011

510(k) Number K000011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2000
Decision Date March 01, 2000
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K000011.
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
K001454 · Micro Therapeutics, Inc. · Jun 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
K001198 · Datascope Corp. · May 2000
AGILITY STEERABLE GUIDEWIRE
K001033 · Cordis Neurovascular, Inc. · Apr 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · Cordis Corp. · Jan 2000
BARD HYDROPHILIC COATED GUIDE WIRES
K993000 · C.R. Bard, Inc. · Nov 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169 · Advanced Cardiovascular Systems, Inc. · Oct 1999