Cleared Traditional

REPLICATION MEDICAL VESSEL GUARD (K082782) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082782 · Replication Medical, Inc. · Cardiovascular device
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Apr 2009
Decision
192d
Days
Class 2
Risk

K082782 is an FDA 510(k) clearance for the REPLICATION MEDICAL VESSEL GUARD. Classified as Vessel Guard Or Cover (product code OMR), Class II - Special Controls.

Submitted by Replication Medical, Inc. (Alexandria, US). The FDA issued a Cleared decision on April 2, 2009 after a review of 192 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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 Replication Medical, Inc. devices

Submission Details

510(k) Number K082782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 22, 2008
Decision Date April 02, 2009
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMR Vessel Guard Or Cover
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition These Device Types Do Not Include Devices Whose Primary Purpose Is To Minimize The Incidence Or Severity Of Adhesion Formation As A Result Of Vascular Surgery. Intended To Protect Vessels From Injury During Surgery (not To Be Confused With Wraps, Patches Or Covers Intended To Facilitate Revision Surgeries). Indicated To Wrap, Patch, Or Cover Intended To Cover Blood Vessels.
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.