Cleared Special

K133282 - REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM

K133282 is an FDA 510(k) clearance for REVERSE MEDICAL MICRO VASCULAR PLUG (MV..., 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 33-day FDA review.

K133282 · Reverse Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
33d
Days
Class 2
Risk

K133282 is an FDA 510(k) clearance for the REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) 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 November 27, 2013 after a review of 33 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 - K133282

510(k) Number K133282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date November 27, 2013
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 K133282.
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
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K132083 · MicroVention, Inc. · Oct 2013
MEDUSA VASCULAR PLUG
K123696 · Endoshape, Inc. · Oct 2013