Cleared Traditional

MICROVEL DOUBLE VELOUR SUPPORTED 100 (K822633) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822633 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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Jul 1983
Decision
315d
Days
Class 2
Risk

K822633 is an FDA 510(k) clearance for the MICROVEL DOUBLE VELOUR SUPPORTED 100. 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. (Walker, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K822633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1982
Decision Date July 12, 1983
Days to Decision 315 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 125d · This submission: 315d
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 57
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K822633.
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K831822 · Shiley, Inc. · Oct 1984
IONESCU-SHILEY LOW POROSITY COMPOSITE
K831865 · Shiley, Inc. · Oct 1983
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K831880 · Shiley, Inc. · Oct 1983
BARD PTFE VASCULAR PROSTHESIS
K821716 · C.R. Bard, Inc. · Aug 1982
FED RINGED-TEX VASCULAR GRAFT
K821158 · W.L. Gore & Associates, Inc. · May 1982
GORE-TEX VASULAR GRAFT
K811510 · W.L. Gore & Associates, Inc. · Aug 1981