Cleared Traditional

SHILEY CORONARY CARDIOPLEGIA ADAPTOR (K843542) - FDA 510(k) Clearance

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

K843542 · Shiley, Inc. · Cardiovascular device
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Oct 1984
Decision
41d
Days
Class 2
Risk

K843542 is an FDA 510(k) clearance for the SHILEY CORONARY CARDIOPLEGIA ADAPTOR. 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 October 18, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 K843542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date October 18, 1984
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 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 K843542.
STOCKERT-SHILEY INTRACARDIAC SUCKERS
K844139 · Shiley, Inc. · Dec 1984
STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH
K844140 · Shiley, Inc. · Dec 1984
ARGYLE SILICONE LEFT VENTRICULAR AND
K843444 · Sherwood Medical Co. · Oct 1984
ARGYLE CUSTOM TUBING PACK
K842889 · Sherwood Medical Co. · Aug 1984
ARGYLE TAPERED VASCULAR SHUNT
K840914 · Sherwood Medical Co. · Apr 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
K833830 · Shiley, Inc. · Apr 1984