Cleared Traditional

LAKE REGION MANUFACTURING GUIDEWIRES (K981326) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981326 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
88d
Days
Class 2
Risk

K981326 is an FDA 510(k) clearance for the LAKE REGION MANUFACTURING GUIDEWIRES. 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 10, 1998 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lake Region Mfg., Inc. devices

Submission Details

510(k) Number K981326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1998
Decision Date July 10, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K981326.
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · Medtronic Vascular · Sep 1999
STRATEGY CORONARY WIRE GUIDE
K983771 · Cook, Inc. · Nov 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713 · C.R. Bard, Inc. · Oct 1998
CORDIS VANGUARD STEERABLE GUIDEWIRES
K974560 · Cordis Corp. · May 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · Cordis Corp. · Jan 1998
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · B.Braun Medical, Inc. · Dec 1997