Cleared Traditional

K970938 - HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING

K970938 is an FDA 510(k) clearance for HUNTER 0.014 INCH SUPER SOFT / HUNTER O..., manufactured by Biocompatibles Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K970938 · Biocompatibles Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
249d
Days
Class 2
Risk

K970938 is an FDA 510(k) clearance for the HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORE.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biocompatibles Cardiovascular, Inc. (Rockville, US). The FDA issued a Cleared decision on November 17, 1997 after a review of 249 days - an extended review cycle.

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 Biocompatibles Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K970938

510(k) Number K970938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1997
Decision Date November 17, 1997
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
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 622
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K970938.
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
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IVT 0.014 PTFE-COATED TRACKWIRE
K971688 · Boston Scientific /International Technologies · Dec 1997
THEROX INFUSION GUIDEWIRES
K971719 · Therox, Inc. · Nov 1997
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
K972944 · Medtronics Interventional Vascular · Nov 1997
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
K972762 · Cardio Metrics, Inc. · Oct 1997