Cleared Traditional

K970657 - LMI THROMBECTOMY CATHETER

K970657 is an FDA 510(k) clearance for LMI THROMBECTOMY 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 130-day FDA review.

K970657 · Lucas Medical, Inc. · Cardiovascular device
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Jul 1997
Decision
130d
Days
Class 2
Risk

K970657 is an FDA 510(k) clearance for the LMI THROMBECTOMY 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 July 1, 1997 after a review of 130 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 - K970657

510(k) Number K970657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1997
Decision Date July 01, 1997
Days to Decision 130 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
5d slower than avg
Panel avg: 125d · This submission: 130d
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 K970657.
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DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997
NEEDLE'S EYE SNARE
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AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995