Cleared Traditional

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH (K010055) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010055 · Cook Vascular, Inc. · Cardiovascular device
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Jun 2001
Decision
157d
Days
Class 2
Risk

K010055 is an FDA 510(k) clearance for the COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Cook Vascular, Inc. (Leechburg, US). The FDA issued a Cleared decision on June 14, 2001 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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

Submission Details

510(k) Number K010055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date June 14, 2001
Days to Decision 157 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
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 28
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K010055.
PRELUDE SHEATH INTRODUCER
K070159 · Merit Medical Systems, Inc. · Jun 2007
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
COAXIAL DILATOR SET
K974640 · Boston Scientific Corp · Mar 1998
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · Cordis Corp. · Apr 1997
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · Shiley, Inc. · Jun 1988