Cleared Traditional

K854487 - VENOUS RETURN CANNULA W/CUFF 91039

K854487 is the FDA 510(k) clearance for VENOUS RETURN CANNULA W/CUFF 91039 by Dlp, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K854487 · Dlp, Inc. · Cardiovascular device
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Feb 1986
Decision
94d
Days
Class 2
Risk

K854487 is an FDA 510(k) clearance for the VENOUS RETURN CANNULA W/CUFF 91039. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Dlp, Inc. devices

Submission Details

510(k) Number K854487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1985
Decision Date February 10, 1986
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K854487.
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · Shiley, Inc. · May 1986
RMI CAROTID BY-PASS SHUNT
K860988 · Research Medical, Inc. · May 1986
VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015
K860149 · Dlp, Inc. · Mar 1986
MODIFIED CORONARY CARDIOPLEGIA ADAPTOR
K854640 · Shiley, Inc. · Feb 1986
SARNS EVACUPLEGE CATHETER
K853128 · 3M Health Care, Sarns · Oct 1985
SHILEY CSD EXTENSION LINE WITH FILTER
K852984 · Shiley, Inc. · Oct 1985