Cleared Special

K040786 - VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING

K040786 is an FDA 510(k) clearance for VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO..., manufactured by Neometrics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 21-day FDA review.

K040786 · Neometrics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2004
Decision
21d
Days
Class 2
Risk

K040786 is an FDA 510(k) clearance for the VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 19, 2004 after a review of 21 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.

View all Neometrics, Inc. devices

FDA 510(k) Submission Details - K040786

510(k) Number K040786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2004
Decision Date April 19, 2004
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 634
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K040786.
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624 · Lake Region Mfg., Inc. · Jul 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
K040825 · Lake Region Mfg., Inc. · May 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · Boston Scientific Corp · Apr 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K040037 · Intra Luminal Therapeutics, Inc. · Mar 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · Ev3, Inc. · Mar 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · Arrow Intl., Inc. · Mar 2004