Cleared Traditional

CATHETER TWO STAGE VENOUS RETURN (K915268) - FDA 510(k) Clearance

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

K915268 · Dlp, Inc. · Cardiovascular device
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Jul 1992
Decision
245d
Days
Class 2
Risk

K915268 is an FDA 510(k) clearance for the CATHETER TWO STAGE VENOUS RETURN. 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 July 27, 1992 after a review of 245 days - an extended review 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: 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 K915268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date July 27, 1992
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 125d · This submission: 245d
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 103
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K915268.
BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA
K930620 · C.R. Bard, Inc. · May 1993
BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU
K930593 · C.R. Bard, Inc. · May 1993
BARD WILLIAM HARVEY AORTIC ARCH CANULAE
K923483 · C.R. Bard, Inc. · Mar 1993
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · C.R. Bard, Inc. · Aug 1990
SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)
K900753 · Shiley, Inc. · Apr 1990
MODIFIED STOCKERT-SHILEY VENOUS CATHETER
K890980 · Shiley, Inc. · May 1989