Cleared Traditional

K854319 - SCHNEIDER-SHILEY PERIPHERAL DILATATION ...

K854319 is an FDA 510(k) clearance for SCHNEIDER-SHILEY PERIPHERAL DILATATION ..., manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K854319

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.

LIT Device Classification - Class 2, Special Controls

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 263
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K854319.
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · Cook, Inc. · Aug 1987
OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE
K862550 · Meadox Surgimed, Inc. · Sep 1986
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · Shiley, Inc. · Aug 1986
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · Advanced Cardiovascular Systems, Inc. · Oct 1985
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER
K844913 · Cordis Corp. · Aug 1985
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
K851854 · Advanced Cardiovascular Systems, Inc. · Aug 1985