Cleared Traditional

K153778 - Nester Embolization Coils, Tornado Embolization Coils

K153778 is an FDA 510(k) clearance for Nester Embolization Coils, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K153778 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
140d
Days
Class 2
Risk

K153778 is an FDA 510(k) clearance for the Nester Embolization Coils, Tornado Embolization Coils. 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 May 19, 2016 after a review of 140 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K153778

510(k) Number K153778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2015
Decision Date May 19, 2016
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K153778.
Gel-Bead
K171946 · Vascular Solutions, Inc. · Oct 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524 · MicroVention, Inc. · Mar 2017
Hilal Embolization MicroCoils
K160219 · Cook Incorporated · Aug 2016
HydroPearl Microspheres, HydroPearl Microspheres
K150870 · MicroVention, Inc. · Dec 2015
MReye Embolization Coils
K150931 · Cook Incorporated · Dec 2015
MReye Flipper Detachable Embolization Coil and Delivery System
K150964 · Cook Incorporated · Dec 2015