Cleared Traditional

SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER (K854319) - FDA 510(k) Clearance

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

K854319 · Shiley, Inc. · Cardiovascular device
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Mar 1986
Decision
154d
Days
Class 2
Risk

K854319 is an FDA 510(k) clearance for the SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K854319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date March 31, 1986
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K854319.
CORDIS PTA DILATATION CATHETERS
K880612 · Cordis Corp. · Jul 1988
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · Cook, Inc. · Aug 1987
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · Shiley, Inc. · Aug 1986
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER
K844913 · Cordis Corp. · Aug 1985
USCI GRUNTZIG DILACA BALLOON DILATION
K830608 · C.R. Bard, Inc. · Mar 1983
CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.
K812168 · Cordis Corp. · Aug 1981