Cleared Traditional

CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA (K901074) - FDA 510(k) Clearance

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

K901074 · Dlp, Inc. · Cardiovascular device
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Jul 1990
Decision
120d
Days
Class 2
Risk

K901074 is an FDA 510(k) clearance for the CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA. 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 6, 1990 after a review of 120 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 K901074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1990
Decision Date July 06, 1990
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
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 K901074.
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
SARNS VENT CATHETER
K890024 · 3M Company · Mar 1989