Cleared Traditional

K864316 - TARGET THERAPEUTICS TAPER GUIDE WIRE

K864316 is the FDA 510(k) clearance for TARGET THERAPEUTICS TAPER GUIDE WIRE by Target Therapeutics. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 501
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