Cleared Traditional

K854640 - MODIFIED CORONARY CARDIOPLEGIA ADAPTOR

K854640 is an FDA 510(k) clearance for MODIFIED CORONARY CARDIOPLEGIA ADAPTOR, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K854640 · Shiley, Inc. · Cardiovascular device
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Feb 1986
Decision
83d
Days
Class 2
Risk

K854640 is an FDA 510(k) clearance for the MODIFIED 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 February 10, 1986 after a review of 83 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

FDA 510(k) Submission Details - K854640

510(k) Number K854640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date February 10, 1986
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K854640.
RMI CAROTID BY-PASS SHUNT
K860988 · Research Medical, Inc. · May 1986
VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015
K860149 · Dlp, Inc. · Mar 1986
VENOUS RETURN CANNULA W/CUFF 91039
K854487 · Dlp, Inc. · Feb 1986
SARNS EVACUPLEGE CATHETER
K853128 · 3M Health Care, Sarns · Oct 1985
SHILEY CSD EXTENSION LINE WITH FILTER
K852984 · Shiley, Inc. · Oct 1985
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU
K851323 · C.R. Bard, Inc. · Aug 1985