Cleared Traditional

K862464 - SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR

K862464 is an FDA 510(k) clearance for SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K862464 · Shiley, Inc. · Cardiovascular device
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Aug 1986
Decision
59d
Days
Class 2
Risk

K862464 is an FDA 510(k) clearance for the SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on August 28, 1986 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 - K862464

510(k) Number K862464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1986
Decision Date August 28, 1986
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 319
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K862464.
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER
K863137 · Terumo Medical Corp. · Oct 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · Medtronic Vascular · Sep 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466 · Shiley, Inc. · Aug 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244 · Cordis Corp. · Aug 1986
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465 · Shiley, Inc. · Aug 1986
ANGIOFLOW
K854910 · Angiomed U.S., Inc. · Jul 1986