Cleared Traditional

K853749 - CUSTOM CORONARY MANIFOLD KITS

K853749 is the FDA 510(k) clearance for CUSTOM CORONARY MANIFOLD KITS by Procedure Products, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K853749 · Procedure Products, Inc. · Cardiovascular device
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Jan 1986
Decision
126d
Days
Class 2
Risk

K853749 is an FDA 510(k) clearance for the CUSTOM CORONARY MANIFOLD KITS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Procedure Products, Inc. (Vancouver, US). The FDA issued a Cleared decision on January 13, 1986 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 870.4290 - 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 Procedure Products, Inc. devices

Submission Details

510(k) Number K853749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date January 13, 1986
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 56
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K853749.
LUER LOCK SKIRT
K862451 · Hewlett-Packard Co. · Oct 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177 · Cordis Corp. · Oct 1986
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
K863661 · Medical Components, Inc. · Sep 1986
HEMOSTATIC SIDEARM
K854397 · Target Therapeutics · Jan 1986
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950 · American Bentley · Dec 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · Advanced Cardiovascular Systems, Inc. · Dec 1985