Cleared Traditional

K820696 - MEADOX WOVEN DOUBLE VELOUR

K820696 is the FDA 510(k) clearance for MEADOX WOVEN DOUBLE VELOUR 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 119-day FDA review.

K820696 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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Jul 1982
Decision
119d
Days
Class 2
Risk

K820696 is an FDA 510(k) clearance for the MEADOX WOVEN DOUBLE VELOUR. 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. (Mchenry, US). The FDA issued a Cleared decision on July 9, 1982 after a review of 119 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

Submission Details

510(k) Number K820696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1982
Decision Date July 09, 1982
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
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 K820696.
VASCULAR GRAFT PROSTHESIS EXPANDED MICR
K830543 · Impra, Inc. · Jul 1983
MICROVEL DOUBLE VELOUR SUPPORTED 100
K822633 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1983
BARD PTFE VASCULAR PROSTHESIS
K821716 · C.R. Bard, Inc. · Aug 1982
HANCOCK VASCULAR GRAFT
K820600 · Extracorporeal Medical Specialities, Inc. · Jul 1982
FED RINGED-TEX VASCULAR GRAFT
K821158 · W.L. Gore & Associates, Inc. · May 1982
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT
K812248 · Meadox Medicals, Div. Boston Scientific Corp. · Nov 1981