Cleared Traditional

K012861 - VASCUPUNCTURE ACCESS WIRE

K012861 is an FDA 510(k) clearance for VASCUPUNCTURE ACCESS WIRE, manufactured by Neometrics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K012861 · Neometrics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2002
Decision
165d
Days
Class 2
Risk

K012861 is an FDA 510(k) clearance for the VASCUPUNCTURE ACCESS WIRE. 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 February 5, 2002 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Neometrics, Inc. devices

FDA 510(k) Submission Details - K012861

510(k) Number K012861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2001
Decision Date February 05, 2002
Days to Decision 165 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 125d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 634
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K012861.
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
K014075 · Baylis Medical Co., Inc. · Mar 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
K020340 · Guidant Corp. · Mar 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · Boston Scientific Corp · Feb 2002
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