Cleared Special

K070487 - SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX

K070487 is an FDA 510(k) clearance for SMARTWIRE PRESSURE GUIDE WIRE, manufactured by Volcano Corporation. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Special 510(k) pathway after a 24-day FDA review.

K070487 · Volcano Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
24d
Days
Class 2
Risk

K070487 is an FDA 510(k) clearance for the SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on March 16, 2007 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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.

FDA 510(k) Submission Details - K070487

510(k) Number K070487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date March 16, 2007
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 63
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K070487.
CARDIA-CATH
K112323 · Millar Instruments, Inc. · Oct 2011
MIKRO-CATH, MODEL 825-0101
K093111 · Millar Instruments, Inc. · Jan 2010
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · Radi Medical Systems AB · Jul 2008
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · Radi Medical Systems AB · Dec 2006
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · Edwards Lifesciences, LLC · Dec 2005
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · Radi Medical Systems AB · Jun 2003
K070487 · SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
Download PDF FDA Summary Volcano Corporation