Cleared Traditional

K961847 - HEMASHIELD VANTAGE (VASCULAR GRAFT

K961847 is the FDA 510(k) clearance for HEMASHIELD VANTAGE (VASCULAR GRAFT by Meadox Medicals, Div. Boston Scientific Corp.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K961847 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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Jan 1997
Decision
254d
Days
Class 2
Risk

K961847 is an FDA 510(k) clearance for the HEMASHIELD VANTAGE (VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 254 days - an extended review cycle.

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

Submission Details

510(k) Number K961847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 13, 1996
Decision Date January 22, 1997
Days to Decision 254 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
129d slower than avg
Panel avg: 125d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 106
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K961847.
UNI-GRAFT K DV
K963790 · Atrium Medical Corp. · Jul 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K971192 · Impra, Inc. · Apr 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1997
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K964197 · Impra, Inc. · Jan 1997
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K962639 · Impra, Inc. · Oct 1996
BARD GRAFT SIZER
K961134 · C.R. Bard, Inc. · Jun 1996