Cleared Traditional

K013024 - SELECTIVA GUIDEWIRE

K013024 is the FDA 510(k) clearance for SELECTIVA GUIDEWIRE by Neometrics, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K013024 · Neometrics, Inc. · Cardiovascular device
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Dec 2001
Decision
88d
Days
Class 2
Risk

K013024 is an FDA 510(k) clearance for the SELECTIVA GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Neometrics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 4, 2001 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neometrics, Inc. devices

Submission Details

510(k) Number K013024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2001
Decision Date December 04, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 439
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K013024.
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · Advanced Cardiovascular Systems, Inc. · Jan 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
K013833 · Guidant Corp. · Jan 2002
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · Guidant Corp. · Dec 2001
BACK-UP MEIER GUIDEWIRE
K011906 · Boston Scientific Corp · Aug 2001
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · Merit Medical Systems, Inc. · Oct 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K002206 · Guidant Corp. · Aug 2000