Cleared Special

STREERABLE PTCA GUIDEWIRE (K011968) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011968 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
30d
Days
Class 2
Risk

K011968 is an FDA 510(k) clearance for the STREERABLE PTCA 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 July 25, 2001 after a review of 30 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

Submission Details

510(k) Number K011968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date July 25, 2001
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K011968.
IQ HYDROPHILIC GUIDE WIRE
K032183 · Boston Scientific Corp · Aug 2003
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · Boston Scientific Corp · Feb 2002
BACK-UP MEIER GUIDEWIRE
K011906 · Boston Scientific Corp · Aug 2001
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · Merit Medical Systems, Inc. · Oct 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
K001198 · Datascope Corp. · May 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · Cordis Corp. · Jan 2000