Cleared Special

K061000 - EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0

K061000 is an FDA 510(k) clearance for EVOLUTION MECHANICAL DILATOR SHEATH SET..., manufactured by Cook Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Special 510(k) pathway after a 29-day FDA review.

K061000 · Cook Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
29d
Days
Class 2
Risk

K061000 is an FDA 510(k) clearance for the EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Cook Vascular, Inc. (Vandergrift, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061000

510(k) Number K061000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2006
Decision Date May 10, 2006
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K061000.
ESTECH PERCUTANEOUS INSERTION DILATOR KIT
K070749 · Coombs Medical Device Consulting · Oct 2007
PRELUDE SHEATH INTRODUCER
K070159 · Merit Medical Systems, Inc. · Jun 2007
STARCLOSE HEX-HUB DILATOR
K062554 · Abbott Vascular, Inc. · Feb 2007
SUPER SHEATH INTRODUCER SHEATH
K052557 · Togo Medikit Co., Ltd. · Jan 2006
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
K061000 · EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
Download PDF FDA Summary Cook Vascular, Inc.