Cleared Special

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K040037) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K040037 · Intra Luminal Therapeutics, Inc. · Cardiovascular device
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Mar 2004
Decision
54d
Days
Class 2
Risk

K040037 is an FDA 510(k) clearance for the MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Intra Luminal Therapeutics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 3, 2004 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intra Luminal Therapeutics, Inc. devices

Submission Details

510(k) Number K040037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2004
Decision Date March 03, 2004
Days to Decision 54 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 225
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K040037.
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · Boston Scientific Corp · Apr 2004
IQ GUIDE WIRE
K040140 · Boston Scientific Corp · Feb 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
K033742 · Boston Scientific Corp · Jan 2004
PERIVAC KIT
K032050 · Boston Scientific Corp · Aug 2003