Cleared Traditional

DUAL LUMEN L-CATH CATHETER SYSTEM (K925979) - FDA 510(k) Clearance

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

K925979 · Luther Medical Products, Inc. · Cardiovascular device
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May 1993
Decision
183d
Days
Class 2
Risk

K925979 is an FDA 510(k) clearance for the DUAL LUMEN L-CATH CATHETER SYSTEM. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Luther Medical Products, Inc. (Tustin, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 183 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. 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 Luther Medical Products, Inc. devices

Submission Details

510(k) Number K925979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date May 27, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
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 226
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K925979.
MAGIC TORQUE GUIDEWIRE
K933334 · Boston Scientific Corp · Jan 1994
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466 · C.R. Bard, Inc. · Oct 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091 · Cordis Corp. · Apr 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074 · C.R. Bard, Inc. · Mar 1993
CORDIS STEERABLE GUIDEWIRE
K925833 · Cordis Corp. · Feb 1993