Cleared Traditional

K974713 - BARD HYDROPHILLIC COATED GUIDE WIRE

K974713 is an FDA 510(k) clearance for BARD HYDROPHILLIC COATED GUIDE WIRE, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K974713 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
301d
Days
Class 2
Risk

K974713 is an FDA 510(k) clearance for the BARD HYDROPHILLIC COATED GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on October 14, 1998 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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. devices

FDA 510(k) Submission Details - K974713

510(k) Number K974713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1997
Decision Date October 14, 1998
Days to Decision 301 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
176d slower than avg
Panel avg: 125d · This submission: 301d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K974713.
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
K983033 · Guidant Corp. · Nov 1998
PIOLAX HYDROPHILIC GUIDEWIRE
K980977 · Piolax Medical Devices, Inc. · Oct 1998
DOCKING-EXTENSION WIRE
K982592 · Schneider (Europe) GmbH · Oct 1998
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K982083 · Guidant Corp. · Sep 1998
CORE AND COIL ASSEMBLY GUIDEWIRE
K971322 · Lake Region Mfg., Inc. · Jul 1998
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1
K981381 · Guidant Corp. · Jul 1998