Cleared Traditional

K010128 - COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

K010128 is an FDA 510(k) clearance for COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE, 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 464-day FDA review.

K010128 · Cook Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
464d
Days
Class 2
Risk

K010128 is an FDA 510(k) clearance for the COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE. 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 April 25, 2002 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cook Vascular, Inc. devices

FDA 510(k) Submission Details - K010128

510(k) Number K010128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date April 25, 2002
Days to Decision 464 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
339d slower than avg
Panel avg: 125d · This submission: 464d
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 K010128.
BD INTROSYTE PRECISION INTRODUCER
K020834 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2002
VALVED PEELABLE INTRODUCER
K021004 · Medamicus, Inc. · Jun 2002
MEDAMICUS AXIA RSN
K020563 · Medamicus, Inc. · May 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · Edwards Lifesciences, LLC · Mar 2002
MODIFICATION TO TRANSSEPTAL INTRODUCER SET
K020090 · Thomas Medical Products, Inc. · Feb 2002
RENAL GUIDING SHEATH
K012854 · Terumo Medical Corp. · Nov 2001