Cleared Special

K021213 - MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS

K021213 is an FDA 510(k) clearance for MODIFICATION TO HEMASHIELD PLATINUM WOV..., 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 2-day FDA review.

K021213 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
2d
Days
Class 2
Risk

K021213 is an FDA 510(k) clearance for the MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS. Classified as Graft, Vascular, Synthetic/biologic Composite (product code MAL), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 19, 2002 after a review of 2 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.

FDA 510(k) Submission Details - K021213

510(k) Number K021213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2002
Decision Date April 19, 2002
Days to Decision 2 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
123d faster than avg
Panel avg: 125d · This submission: 2d
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 K021213.
ALBOGRAFT VASCULAR PROSTHESIS
K103080 · LeMaitre Vascular, Inc. · Jan 2011
ALBOGRAFT VASCULAR PROSTHESIS
K093231 · LeMaitre Vascular, Inc. · Jan 2010
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
K052302 · Boston Scientific Corp · Sep 2005
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
K954848 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996
K021213 · MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
Download PDF FDA Summary Boston Scientific Corp