Cleared Traditional

K031442 - PBN GUIDEWIRES

K031442 is an FDA 510(k) clearance for PBN GUIDEWIRES, manufactured by Medical Device Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K031442 · Medical Device Technologies, Inc. · Cardiovascular device
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Aug 2003
Decision
99d
Days
Class 2
Risk

K031442 is an FDA 510(k) clearance for the PBN GUIDEWIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 13, 2003 after a review of 99 days - within the typical 510(k) review window.

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 Medical Device Technologies, Inc. devices

FDA 510(k) Submission Details - K031442

510(k) Number K031442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2003
Decision Date August 13, 2003
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 704
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K031442.
VASCUPUNCTURE PICC GUIDEWIRE
K031652 · Neometrics, Inc. · Sep 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615 · Asahi Intecc Co., Ltd. · Sep 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K031678 · Guidant Corp. · Aug 2003
PERIVAC KIT
K032050 · Boston Scientific Corp · Aug 2003
IQ HYDROPHILIC GUIDE WIRE
K032183 · Boston Scientific Corp · Aug 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · Boston Scientific Scimed, Inc. · May 2003