Cleared Special

K040037 - MODIFICATION TO SAFE-CROSS RADIO FREQUE...

K040037 is an FDA 510(k) clearance for MODIFICATION TO SAFE-CROSS RADIO FREQUE..., manufactured by Intra Luminal Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 54-day FDA review.

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

FDA 510(k) Submission Details - K040037

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 599
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K040037.
LAKE REGION HYDROPHILIC GUIDEWIRE
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K040867 · Boston Scientific Corp · Apr 2004
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
K040786 · Neometrics, Inc. · Apr 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · Ev3, Inc. · Mar 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · Arrow Intl., Inc. · Mar 2004
IQ GUIDE WIRE
K040140 · Boston Scientific Corp · Feb 2004