Cleared Traditional

K150964 - MReye Flipper Detachable Embolization Coil and Delivery System

K150964 is an FDA 510(k) clearance for MReye Flipper Detachable Embolization C..., 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 252-day FDA review.

K150964 · Cook Incorporated · Cardiovascular device
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Dec 2015
Decision
252d
Days
Class 2
Risk

K150964 is an FDA 510(k) clearance for the MReye Flipper Detachable Embolization Coil and Delivery System. 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 December 18, 2015 after a review of 252 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

FDA 510(k) Submission Details - K150964

510(k) Number K150964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2015
Decision Date December 18, 2015
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
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 K150964.
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
AZUR CX Detachable 35 Coils
K151358 · MicroVention, Inc. · Sep 2015
LifePearl Microshperes
K150958 · MicroVention, Inc. · Sep 2015
Retracta Detachable Embolization Coil
K151676 · Cook Incorporated · Jul 2015