Cleared Traditional

K954848 - HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT

K954848 is an FDA 510(k) clearance for HEMASHIELD MICROVEL VELOUR KNITTED VASC..., manufactured by Meadox Medicals, Div. Boston Scientific Corp.. The device is a Class 2 Cardiovascular device with product code MAL cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K954848 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
101d
Days
Class 2
Risk

K954848 is an FDA 510(k) clearance for the HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT. Classified as Graft, Vascular, Synthetic/biologic Composite (product code MAL), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on February 1, 1996 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 Meadox Medicals, Div. Boston Scientific Corp. devices

FDA 510(k) Submission Details - K954848

510(k) Number K954848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received October 23, 1995
Decision Date February 01, 1996
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K954848.
ALBOGRAFT VASCULAR PROSTHESIS
K093231 · LeMaitre Vascular, Inc. · Jan 2010
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
K052302 · Boston Scientific Corp · Sep 2005
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213 · Boston Scientific Corp · Apr 2002