Cleared Traditional

K864316 - TARGET THERAPEUTICS TAPER GUIDE WIRE

K864316 is an FDA 510(k) clearance for TARGET THERAPEUTICS TAPER GUIDE WIRE, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K864316 · Target Therapeutics · Cardiovascular device
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Mar 1987
Decision
137d
Days
Class 2
Risk

K864316 is an FDA 510(k) clearance for the TARGET THERAPEUTICS TAPER GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Target Therapeutics (Los Angeles, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 137 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 Target Therapeutics devices

FDA 510(k) Submission Details - K864316

510(k) Number K864316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date March 20, 1987
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 690
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K864316.
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · Advanced Cardiovascular Systems, Inc. · Aug 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
K871137 · Dlp, Inc. · Jul 1987
GUIDE WIRE
K870664 · Datascope Corp. · Mar 1987
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