Cleared Traditional

LMI IRRIGATION CATHETER (IGR) (K972623) - FDA 510(k) Clearance

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

K972623 · Lucas Medical, Inc. · Cardiovascular device
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Nov 1997
Decision
128d
Days
Class 2
Risk

K972623 is an FDA 510(k) clearance for the LMI IRRIGATION CATHETER (IGR). 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 November 19, 1997 after a review of 128 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

Submission Details

510(k) Number K972623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date November 19, 1997
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K972623.
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