Cleared Traditional

K955125 - LMI OCCLUSION CATHETER

K955125 is an FDA 510(k) clearance for LMI OCCLUSION CATHETER, manufactured by Lucas Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K955125 · Lucas Medical, Inc. · Cardiovascular device
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Mar 1996
Decision
123d
Days
Class 2
Risk

K955125 is an FDA 510(k) clearance for the LMI OCCLUSION CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Lucas Medical, Inc. (Anaheim, US). The FDA issued a Cleared decision on March 11, 1996 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Lucas Medical, Inc. devices

FDA 510(k) Submission Details - K955125

510(k) Number K955125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1995
Decision Date March 11, 1996
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 37
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K955125.
LATIS GRAFT CLEANING CATHETER
K973465 · Applied Medical Resources · Feb 1998
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993
ARTERIAL EMBOLECTOMY CATHETER
K900311 · Impra, Inc. · Jul 1990