Cleared Traditional

Hilal Embolization MicroCoils (K160219) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160219 · Cook Incorporated · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
187d
Days
Class 2
Risk

K160219 is an FDA 510(k) clearance for the Hilal Embolization MicroCoils. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 3, 2016 after a review of 187 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 Incorporated devices

Submission Details

510(k) Number K160219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2016
Decision Date August 03, 2016
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
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 83
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K160219.
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
K173891 · Vascular Solutions, Inc. · Jan 2018
Gel-Bead
K171946 · Vascular Solutions, Inc. · Oct 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524 · MicroVention, Inc. · Mar 2017
Nester Embolization Coils, Tornado Embolization Coils
K153778 · Cook Incorporated · May 2016
HydroPearl Microspheres, HydroPearl Microspheres
K150870 · MicroVention, Inc. · Dec 2015
MReye Embolization Coils
K150931 · Cook Incorporated · Dec 2015