Cleared Traditional

K914786 - TARGET THERAPEUTICS COILS

K914786 is an FDA 510(k) clearance for TARGET THERAPEUTICS COILS, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K914786 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
180d
Days
Class 2
Risk

K914786 is an FDA 510(k) clearance for the TARGET THERAPEUTICS COILS. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on April 20, 1992 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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.

FDA 510(k) Submission Details - K914786

510(k) Number K914786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date April 20, 1992
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 132
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K914786.
FIBERED PLATINUM COIL, .035 TYPE
K955293 · Target Therapeutics · Feb 1996
COIL POSITIONER SET
K940189 · Cook, Inc. · Nov 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
K940982 · Cook, Inc. · Oct 1994
SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02
K892446 · Shiley, Inc. · Jul 1989
INTERSEPT* OXYGEN GAS LINE FILTER
K882136 · Medtronic Blood Systems, Inc. · Aug 1988
SILICONE OIL 350 CNETISTOKE
K854273 · Pacific Medical Industries · Nov 1985
K914786 · TARGET THERAPEUTICS COILS
Download PDF FDA Summary Target Therapeutics