Cleared Special

K031505 - RAPIDO CUT-AWAY GUIDING CATHETER

K031505 is an FDA 510(k) clearance for RAPIDO CUT-AWAY GUIDING CATHETER, manufactured by Guidant Corporation. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 42-day FDA review.

K031505 · Guidant Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2003
Decision
42d
Days
Class 2
Risk

K031505 is an FDA 510(k) clearance for the RAPIDO CUT-AWAY GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Guidant Corporation (St Paul, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Guidant Corporation devices

FDA 510(k) Submission Details - K031505

510(k) Number K031505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2003
Decision Date June 25, 2003
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 600
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K031505.
RAPIDO CUT-AWAY CUTTER
K031459 · Guidant Corp. · Jul 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
K031211 · Medtronic Vascular · Jul 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · Cook, Inc. · Jun 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · NuMED, Inc. · May 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779 · Medtronic Vascular · Apr 2003
STEREOTAXIS CATHETER ADVANCER SYSTEM
K021802 · Stereotaxis, Inc. · Apr 2003