Cleared Traditional

K960718 - LRM

K960718 is an FDA 510(k) clearance for LRM, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K960718 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
90d
Days
Class 2
Risk

K960718 is an FDA 510(k) clearance for the LRM. 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 May 21, 1996 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K960718

510(k) Number K960718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date May 21, 1996
Days to Decision 90 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K960718.
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
K961777 · Cardio Metrics, Inc. · Jul 1996
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K961445 · Terumo Medical Corp. · Jul 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271 · C.R. Bard, Inc. · Jun 1996
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
K961015 · Scimed Life Systems, Inc. · May 1996
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
K960563 · Scimed Life Systems, Inc. · Apr 1996
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657 · Scimed Life Systems, Inc. · Apr 1996