Cleared Special

K043398 - MODIFICATION TO VASCUPUNCTURE PICC GUID...

K043398 is the FDA 510(k) clearance for MODIFICATION TO VASCUPUNCTURE PICC GUID... by Neometrics, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 81-day FDA review.

K043398 · Neometrics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
81d
Days
Class 2
Risk

K043398 is an FDA 510(k) clearance for the MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE. 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 March 1, 2005 after a review of 81 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

Submission Details

510(k) Number K043398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2004
Decision Date March 01, 2005
Days to Decision 81 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

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 K043398.
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
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ASAHI PTCA GUIDE WIRE FIELDER
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GALEO FOCUS GUIDE WIRE
K042373 · Biotronik, Inc. · Mar 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422 · Asahi Intecc Co., Ltd. · Jan 2005
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004