Cleared Traditional

K150964 - MReye Flipper Detachable Embolization C...

K150964 is the FDA 510(k) clearance for MReye Flipper Detachable Embolization C... by Cook Incorporated. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 89
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