Cleared Traditional

SCHNEIDER-SHILEY GUIDE WIRE (K864787) - FDA 510(k) Clearance

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

K864787 · Shiley, Inc. · Cardiovascular device
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Feb 1987
Decision
73d
Days
Class 2
Risk

K864787 is an FDA 510(k) clearance for the SCHNEIDER-SHILEY GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shiley, Inc. devices

Submission Details

510(k) Number K864787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1986
Decision Date February 19, 1987
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 251
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K864787.
CORDIS STEERABLE GUIDEWIRE
K873403 · Cordis Corp. · Mar 1988
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · Olympus Corp. · Nov 1987
GUIDE WIRE
K870664 · Datascope Corp. · Mar 1987
TERUMO RADIFOCUS GUIDE WIRE
K863138 · Terumo Medical Corp. · Nov 1986
SCHNEIDER-SHILEY WIRE TORQUER
K861606 · Shiley, Inc. · Jun 1986
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983