Cleared Traditional

K082094 - BARD PTFE (TEFLON) COATED GUIDE WIRES

K082094 is an FDA 510(k) clearance for BARD PTFE (TEFLON) COATED GUIDE WIRES, manufactured by C.R. Bard Inc., Bard Electrophysiology Division. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K082094 · C.R. Bard Inc., Bard Electrophysiology Division · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
146d
Days
Class 2
Risk

K082094 is an FDA 510(k) clearance for the BARD PTFE (TEFLON) COATED GUIDE WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by C.R. Bard Inc., Bard Electrophysiology Division (Lowell, US). The FDA issued a Cleared decision on December 17, 2008 after a review of 146 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 C.R. Bard Inc., Bard Electrophysiology Division devices

FDA 510(k) Submission Details - K082094

510(k) Number K082094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2008
Decision Date December 17, 2008
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
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 616
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K082094.
HI-TORQUE VERSACORE GUIDE WIRE
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ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
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FREEWAY AND RAILRUNNER GUIDEWIRES
K082922 · Lake Region Mfg., Inc. · Dec 2008
VISION WIRE CORONARY GUIDEWIRE
K082935 · Biotronik, Inc. · Dec 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
K083146 · Asahi Intecc Co., Ltd. · Nov 2008