Cleared Traditional

K023937 - COOK VASCULAR SERPENTA CORONARY SINUS I...

K023937 is an FDA 510(k) clearance for COOK VASCULAR SERPENTA CORONARY SINUS I..., manufactured by Cook Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K023937 · Cook Vascular, Inc. · Cardiovascular device
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May 2003
Decision
182d
Days
Class 2
Risk

K023937 is an FDA 510(k) clearance for the COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook Vascular, Inc. (Leechburg, US). The FDA issued a Cleared decision on May 27, 2003 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Cook Vascular, Inc. devices

FDA 510(k) Submission Details - K023937

510(k) Number K023937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2002
Decision Date May 27, 2003
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 483
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K023937.
APEEL CS CATHETER DELIVERY SYSTEM
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EDWARDS INTRODUCER SHEATH
K031087 · Edwards Lifesciences, LLC · Apr 2003
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K030905 · Medamicus, Inc. · Apr 2003
CO-AXIAL INTRODUCER NEEDLE
K022634 · Promex, Inc. · Nov 2002