Cleared Traditional

K872043 - CHURCHILL INTER-CARDIAC SUCKER

K872043 is an FDA 510(k) clearance for CHURCHILL INTER-CARDIAC SUCKER, manufactured by Churchill Corp.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K872043 · Churchill Corp. · Cardiovascular device
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Sep 1987
Decision
126d
Days
Class 2
Risk

K872043 is an FDA 510(k) clearance for the CHURCHILL INTER-CARDIAC SUCKER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on September 30, 1987 after a review of 126 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 Churchill Corp. devices

FDA 510(k) Submission Details - K872043

510(k) Number K872043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date September 30, 1987
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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 331
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K872043.
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · 3M Health Care, Sarns · Feb 1988
ARGYLE CARDIOPLEGIA CANNULA
K874834 · Sherwood Medical Co. · Jan 1988
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · 3M Health Care, Sarns · Nov 1987
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
K872788 · Uresil Corp. · Sep 1987
TORAY ANTHRON AORTA BYPASS TUBES
K872762 · Toray Industries (America), Inc. · Sep 1987
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · Shiley, Inc. · Aug 1987