Cleared Traditional

K940189 - COIL POSITIONER SET

K940189 is an FDA 510(k) clearance for COIL POSITIONER SET, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K940189 · Cook, Inc. · Cardiovascular device
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Nov 1994
Decision
319d
Days
Class 2
Risk

K940189 is an FDA 510(k) clearance for the COIL POSITIONER SET. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cook, Inc. devices

FDA 510(k) Submission Details - K940189

510(k) Number K940189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1994
Decision Date November 28, 1994
Days to Decision 319 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
194d slower than avg
Panel avg: 125d · This submission: 319d
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 120
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K940189.
EMBOLIZATION COIL SYSTEM
K992121 · Cook, Inc. · Dec 1999
BERENSTEIN COIL
K964112 · Target Therapeutics · Feb 1997
FIBERED PLATINUM COIL, .035 TYPE
K955293 · Target Therapeutics · Feb 1996
ARTERIAL EMBOLIZATION DEVICE (KRD)
K940982 · Cook, Inc. · Oct 1994
TARGET THERAPEUTICS COILS
K914786 · Target Therapeutics · Apr 1992
SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02
K892446 · Shiley, Inc. · Jul 1989