Cleared Traditional

K021606 - EN-SNARE ENDOVASCULAR SNARE AND CATHETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021606 · Medical Device Technologies, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
15d
Days
Class 2
Risk

K021606 is an FDA 510(k) clearance for the EN-SNARE ENDOVASCULAR SNARE AND CATHETER. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 31, 2002 after a review of 15 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 Medical Device Technologies, Inc. devices

Submission Details

510(k) Number K021606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date May 31, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 31
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K021606.
LimFlow V-Ceiver
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Amplatz Goose Neck Snare Kit
K241259 · Medtronic, Inc. · Jun 2024
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K232443 · Argon Medical Devices, Inc. · Sep 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · Cook Incorporated · May 2023
LimFlow V-Ceiver
K222083 · LimFlow, Inc. · Aug 2022
Aveir Retrieval Catheter
K213494 · Abbott Medical · Apr 2022