Cleared Traditional

K123803 - REVERSE MEDICAL MICRO VASCULAR PLUG (MV...

K123803 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 Traditional 510(k) pathway after a 204-day FDA review.

K123803 · Reverse Medical Corporation · Cardiovascular device
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Jul 2013
Decision
204d
Days
Class 2
Risk

K123803 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 July 2, 2013 after a review of 204 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 Reverse Medical Corporation devices

FDA 510(k) Submission Details - K123803

510(k) Number K123803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date July 02, 2013
Days to Decision 204 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
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 98
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K123803.
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