Cleared Special

K052302 - HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION

K052302 is an FDA 510(k) clearance for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code MAL cleared through the Special 510(k) pathway after a 19-day FDA review.

K052302 · Boston Scientific Corp · Cardiovascular device
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Sep 2005
Decision
19d
Days
Class 2
Risk

K052302 is an FDA 510(k) clearance for the HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION. Classified as Graft, Vascular, Synthetic/biologic Composite (product code MAL), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on September 12, 2005 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K052302

510(k) Number K052302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2005
Decision Date September 12, 2005
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

MAL Device Classification - Class 2, Special Controls

Product Code MAL Graft, Vascular, Synthetic/biologic Composite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - MAL Graft, Vascular, Synthetic/biologic Composite

Devices cleared under the same product code (MAL) and FDA review panel - the closest regulatory comparables to K052302.
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX
K122612 · Maquet Cardiovascular, LLC · Sep 2012
ALBOGRAFT VASCULAR PROSTHESIS
K103080 · LeMaitre Vascular, Inc. · Jan 2011
ALBOGRAFT VASCULAR PROSTHESIS
K093231 · LeMaitre Vascular, Inc. · Jan 2010
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213 · Boston Scientific Corp · Apr 2002
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
K954848 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996