Cleared Special

K023700 - PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE

K023700 is an FDA 510(k) clearance for PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE, manufactured by Precision Vascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 30-day FDA review.

K023700 · Precision Vascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
30d
Days
Class 2
Risk

K023700 is an FDA 510(k) clearance for the PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Precision Vascular Systems, Inc. (West Valley City, US). The FDA issued a Cleared decision on December 4, 2002 after a review of 30 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.

FDA 510(k) Submission Details - K023700

510(k) Number K023700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2002
Decision Date December 04, 2002
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 768
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K023700.
NITREX NITINOL GUIDEWIRE
K024021 · Ev3 Corporation · Jan 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · Guidant Corp. · Jan 2003
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
K022762 · Jomed, Inc. · Dec 2002
ENDOVASCULAR GUIDE WIRE
K021363 · Stereotaxis, Inc. · Nov 2002
HI-TORQUE WHISPER LS
K023300 · Guidant Corp. · Oct 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K022357 · Boston Scientific, Target · Oct 2002
K023700 · PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
Download PDF FDA Summary Precision Vascular Sy…