Cleared Traditional

K863138 - TERUMO RADIFOCUS GUIDE WIRE

K863138 is an FDA 510(k) clearance for TERUMO RADIFOCUS GUIDE WIRE, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K863138 · Terumo Medical Corp. · Cardiovascular device
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Nov 1986
Decision
97d
Days
Class 2
Risk

K863138 is an FDA 510(k) clearance for the TERUMO RADIFOCUS GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on November 20, 1986 after a review of 97 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K863138

510(k) Number K863138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date November 20, 1986
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K863138.
AMPLATZ MOVEABLE CORE GUIDEWIRE
K864058 · Lake Region Mfg., Inc. · Feb 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · Shiley, Inc. · Feb 1987
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585 · Advanced Cardiovascular Systems, Inc. · Dec 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983 · Target Therapeutics · Sep 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · Advanced Cardiovascular Systems, Inc. · Sep 1986
ACS WIRE SHAPER
K862567 · Advanced Cardiovascular Systems, Inc. · Sep 1986