Cleared Traditional

K961847 - HEMASHIELD VANTAGE (VASCULAR GRAFT

K961847 is an FDA 510(k) clearance for HEMASHIELD VANTAGE (VASCULAR GRAFT, manufactured by Meadox Medicals, Div. Boston Scientific Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K961847

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.

DSY Device Classification - Class 2, Special Controls

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 159
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K961847.
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1997
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959 · Vascutek, Ltd. · Mar 1997
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
K964665 · Carbomedics, Inc. · Feb 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