Cleared Traditional

SCHNEIDER-SHILEY WIRE TORQUER (K861606) - FDA 510(k) Clearance

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

K861606 · Shiley, Inc. · Cardiovascular device
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Jun 1986
Decision
41d
Days
Class 2
Risk

K861606 is an FDA 510(k) clearance for the SCHNEIDER-SHILEY WIRE TORQUER. 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 June 9, 1986 after a review of 41 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 K861606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date June 09, 1986
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 K861606.
GUIDE WIRE
K870664 · Datascope Corp. · Mar 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · Shiley, Inc. · Feb 1987
TERUMO RADIFOCUS GUIDE WIRE
K863138 · Terumo Medical Corp. · Nov 1986
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 1983
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · Cordis Corp. · Jul 1979