Cleared Special

K150108 - Reverse Medical Micro Vascular Plug System

K150108 is an FDA 510(k) clearance for Reverse Medical Micro Vascular Plug System, manufactured by Reverse Medical Corporation. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Special 510(k) pathway after a 92-day FDA review.

K150108 · Reverse Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
92d
Days
Class 2
Risk

K150108 is an FDA 510(k) clearance for the Reverse Medical Micro Vascular Plug System. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Reverse Medical Corporation (Irvine, US). The FDA issued a Cleared decision on April 22, 2015 after a review of 92 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. 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. Standard predicate reliance. 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 - K150108

510(k) Number K150108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date April 22, 2015
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
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 K150108.
LifePearl Microshperes
K150958 · MicroVention, Inc. · Sep 2015
QuadraSphere Microspheres
K151187 · Biosphere Medical, S.A. · Jul 2015
Retracta Detachable Embolization Coil
K151676 · Cook Incorporated · Jul 2015
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
K133924 · Artventive Medical Group, Inc. · Dec 2014
MEDUSA VASCULAR PLUG,
K140796 · Endoshape, Inc. · Dec 2014
Gel-Block 10X embolization pledgets
K143038 · Vascular Solutions, Inc. · Nov 2014