Cleared Traditional

K010055 - COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

K010055 is an FDA 510(k) clearance for COOK VASCULAR ELECTROSURGICAL DISSECTIO..., manufactured by Cook Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K010055 · Cook Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K010055

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
Combination Product No
PCCP Authorized No
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.

DRE Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K010055.
GELBFISH FLEX VASCULAR DILATOR
K030260 · Vascumetrix, LLC · Feb 2003
MODIFICATION TO GELBFISH VASCULAR DILATORS
K023507 · Vascumetrix, LLC · Nov 2002
GELBISH VASCULAR DILATOR
K012256 · Vascumetrix, LLC · Dec 2001
COAXIAL DILATOR SET
K000737 · Xentek Medical, Inc. · Aug 2000
PERIPHERAL VASCULAR DILATOR
K974617 · Endovascular Instruments, Inc. · Dec 1998
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · Uresil Corp. · Apr 1998
K010055 · COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
Download PDF FDA Summary Cook Vascular, Inc.