Cleared Special

K050926 - TEXAN LONGHORN FOREIGN BODY RETRIEVAL D...

K050926 is an FDA 510(k) clearance for TEXAN LONGHORN FOREIGN BODY RETRIEVAL D..., manufactured by Idev Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Special 510(k) pathway after a 26-day FDA review.

K050926 · Idev Technologies, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2005
Decision
26d
Days
Class 2
Risk

K050926 is an FDA 510(k) clearance for the TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Idev Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on May 9, 2005 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Idev Technologies, Inc. devices

FDA 510(k) Submission Details - K050926

510(k) Number K050926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2005
Decision Date May 09, 2005
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

MMX Device Classification - Class 2, Special Controls

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - MMX Device, Percutaneous Retrieval

All 22
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K050926.
MERIT ONE SNARE SYSTEM
K122088 · Merit Medical Systems, Inc. · Dec 2012
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · Cook, Inc. · Nov 2011
EN SNARE ENDOVASCULAR SNARE SYSTEM
K092343 · Merit Medical Systems, Inc. · Aug 2009
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K021606 · Medical Device Technologies, Inc. · May 2002