Cleared Traditional

STOCKERT-SHILEY AORTIC ROOT CANNULAE (K861310) - FDA 510(k) Clearance

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

K861310 · Shiley, Inc. · Cardiovascular device
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May 1986
Decision
52d
Days
Class 2
Risk

K861310 is an FDA 510(k) clearance for the STOCKERT-SHILEY AORTIC ROOT CANNULAE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on May 30, 1986 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 K861310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date May 30, 1986
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 122
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K861310.
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · Shiley, Inc. · Aug 1987
ARGYLE VASCULAR BYPASS SET
K871844 · Sherwood Medical Co. · Aug 1987
BARD-PARKER CAROTID SHUNT
K860136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · Shiley, Inc. · May 1986
MODIFIED CORONARY CARDIOPLEGIA ADAPTOR
K854640 · Shiley, Inc. · Feb 1986
SHILEY CSD EXTENSION LINE WITH FILTER
K852984 · Shiley, Inc. · Oct 1985