Cleared Traditional

K033188 - TEXAN FOREIGN BODY RETRIEVAL DEVICE

K033188 is an FDA 510(k) clearance for TEXAN FOREIGN BODY RETRIEVAL DEVICE, manufactured by Idev Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K033188 · Idev Technologies, Inc. · Cardiovascular device
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Nov 2003
Decision
49d
Days
Class 2
Risk

K033188 is an FDA 510(k) clearance for the TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050. 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 November 19, 2003 after a review of 49 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Idev Technologies, Inc. devices

FDA 510(k) Submission Details - K033188

510(k) Number K033188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2003
Decision Date November 19, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K033188.
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