Cleared Traditional

K925979 - DUAL LUMEN L-CATH CATHETER SYSTEM

K925979 is an FDA 510(k) clearance for DUAL LUMEN L-CATH CATHETER SYSTEM, manufactured by Luther Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 183-day FDA review.

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

FDA 510(k) Submission Details - K925979

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
Combination Product No
PCCP Authorized No
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.

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 699
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K925979.
SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI
K931577 · Schneider Intl., Ltd. · Jun 1993
TERUMO CORONARY GUIDE WIRE
K925852 · Terumo Medical Corp. · Jun 1993
DOC-TITE(TM) GUIDE WIRE EXTENSION
K931171 · Advanced Cardiovascular Systems, Inc. · Jun 1993
CATHETER GUIDEWIRE (PERIPHERAL USE)
K930961 · Target Therapeutics · May 1993
MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE
K925342 · Medtronics Interventional Vascular · May 1993
AMPLATZ GUIDEWIRES
K930622 · Meadox Medicals, Div. Boston Scientific Corp. · Apr 1993