Cleared Special

K151676 - Retracta Detachable Embolization Coil

K151676 is an FDA 510(k) clearance for Retracta Detachable Embolization Coil, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Special 510(k) pathway after a 30-day FDA review.

K151676 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
30d
Days
Class 2
Risk

K151676 is an FDA 510(k) clearance for the Retracta Detachable Embolization Coil. 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 July 22, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K151676

510(k) Number K151676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2015
Decision Date July 22, 2015
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 129
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K151676.
AZUR CX Detachable 35 Coils
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LifePearl Microshperes
K150958 · MicroVention, Inc. · Sep 2015
QuadraSphere Microspheres
K151187 · Biosphere Medical, S.A. · Jul 2015
Reverse Medical Micro Vascular Plug System
K150108 · Reverse Medical Corporation · Apr 2015
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
K133924 · Artventive Medical Group, Inc. · Dec 2014
MEDUSA VASCULAR PLUG,
K140796 · Endoshape, Inc. · Dec 2014
K151676 · Retracta Detachable Embolization Coil
Download PDF FDA Summary Cook Incorporated