Cleared Special

K023507 - MODIFICATION TO GELBFISH VASCULAR DILATORS

K023507 is an FDA 510(k) clearance for MODIFICATION TO GELBFISH VASCULAR DILATORS, manufactured by Vascumetrix, LLC. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Special 510(k) pathway after a 21-day FDA review.

K023507 · Vascumetrix, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
21d
Days
Class 2
Risk

K023507 is an FDA 510(k) clearance for the MODIFICATION TO GELBFISH VASCULAR DILATORS. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Vascumetrix, LLC (Mesa, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 21 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 - K023507

510(k) Number K023507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2002
Decision Date November 08, 2002
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 103
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K023507.
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
GELBFISH FLEX VASCULAR DILATOR
K030260 · Vascumetrix, LLC · Feb 2003
GELBISH VASCULAR DILATOR
K012256 · Vascumetrix, LLC · Dec 2001
COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
K010055 · Cook Vascular, Inc. · Jun 2001
COAXIAL DILATOR SET
K000737 · Xentek Medical, Inc. · Aug 2000
K023507 · MODIFICATION TO GELBFISH VASCULAR DILATORS
Download PDF FDA Summary Vascumetrix, LLC