Cleared Traditional

IONESCU-SHILEY LOW POROSITY AORTIC GRAFT (K831880) - FDA 510(k) Clearance

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

K831880 · Shiley, Inc. · Cardiovascular device
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Oct 1983
Decision
128d
Days
Class 2
Risk

K831880 is an FDA 510(k) clearance for the IONESCU-SHILEY LOW POROSITY AORTIC GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 128 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 Shiley, Inc. devices

Submission Details

510(k) Number K831880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date October 19, 1983
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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 K831880.
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · Edward Weck, Inc. · Aug 1987
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K831822 · Shiley, Inc. · Oct 1984
IONESCU-SHILEY LOW POROSITY COMPOSITE
K831865 · 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