Cleared Traditional

K861606 - SCHNEIDER-SHILEY WIRE TORQUER

K861606 is an FDA 510(k) clearance for SCHNEIDER-SHILEY WIRE TORQUER, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 41-day FDA review.

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

FDA 510(k) Submission Details - K861606

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.

DQX Device Classification - Class 2, Special Controls

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 540
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K861606.
ACS WIRE SHAPER
K862567 · Advanced Cardiovascular Systems, Inc. · Sep 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
K860430 · Meadox Surgimed, Inc. · Jul 1986
SNAP-ON TORQUER
K862409 · Advanced Cardiovascular Systems, Inc. · Jul 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765 · Advanced Cardiovascular Systems, Inc. · May 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
K861574 · Advanced Cardiovascular Systems, Inc. · May 1986
TELEFLEX TEFLON COATED GUIDEWIRE
K860258 · Teleflexmedical, Inc. · May 1986