Cleared Special

GELBFISH FLEX VASCULAR DILATOR (K030260) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030260 · Vascumetrix, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
27d
Days
Class 2
Risk

K030260 is an FDA 510(k) clearance for the GELBFISH FLEX VASCULAR DILATOR. 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 February 20, 2003 after a review of 27 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.

View all Vascumetrix, LLC devices

Submission Details

510(k) Number K030260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date February 20, 2003
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 31
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K030260.
PRELUDE SHEATH INTRODUCER
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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