Cleared Traditional

K833112 - TUBING FOR CARDIOPULMONARY BYPASS

K833112 is an FDA 510(k) clearance for TUBING FOR CARDIOPULMONARY BYPASS, manufactured by Cardio Med Supplies, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K833112 · Cardio Med Supplies, Inc. · Cardiovascular device
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Nov 1983
Decision
104d
Days
Class 2
Risk

K833112 is an FDA 510(k) clearance for the TUBING FOR CARDIOPULMONARY BYPASS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cardio Med Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 104 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 Cardio Med Supplies, Inc. devices

FDA 510(k) Submission Details - K833112

510(k) Number K833112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date November 28, 1983
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
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 335
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K833112.
ARTERIAL CANNULA CURVED BEVELED TIP
K840002 · Dlp, Inc. · Feb 1984
SARNS CARDIOPLEGIA CANNULA Y
K834025 · 3M Health Care, Sarns · Jan 1984
INFANT VENT CATHETER 12001 W/SIDE VENT
K834039 · Dlp, Inc. · Jan 1984
AXIOM PERFUSSION CANNULA
K832475 · Axiom Medical, Inc. · Oct 1983
UNIVERSAL CORONARY CANNULA
K831330 · Possis Medical, Inc. · Aug 1983
ARGYLE DUAL STAGE VENOUS RETURN CATH.
K831332 · Sherwood Medical Co. · Jun 1983