Cleared Special

K050915 - SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUS...

K050915 is an FDA 510(k) clearance for SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUS..., 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 56-day FDA review.

K050915 · Intra Luminal Therapeutics, Inc. · Cardiovascular device
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Jun 2005
Decision
56d
Days
Class 2
Risk

K050915 is an FDA 510(k) clearance for the SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]. 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 June 7, 2005 after a review of 56 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 - K050915

510(k) Number K050915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2005
Decision Date June 07, 2005
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 K050915.
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