Cleared Traditional

K992121 - EMBOLIZATION COIL SYSTEM

K992121 is the FDA 510(k) clearance for EMBOLIZATION COIL SYSTEM by Cook, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K992121 · Cook, Inc. · Cardiovascular device
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Dec 1999
Decision
180d
Days
Class 2
Risk

K992121 is an FDA 510(k) clearance for the EMBOLIZATION COIL SYSTEM. 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 December 20, 1999 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.

View all Cook, Inc. devices

Submission Details

510(k) Number K992121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1999
Decision Date December 20, 1999
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.

Device Classification

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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K992121.
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
K040342 · Boston Scientific Corp · Apr 2004
CONTOUR SE MICROSPHERES
K034068 · Boston Scientific Corp · Mar 2004
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · Cook, Inc. · Jan 2000
BERENSTEIN COIL
K964112 · Target Therapeutics · Feb 1997
FIBERED PLATINUM COIL, .035 TYPE
K955293 · Target Therapeutics · Feb 1996
COIL POSITIONER SET
K940189 · Cook, Inc. · Nov 1994