Cleared Traditional

K022201 - RADIUS MICRO SNARE

K022201 is an FDA 510(k) clearance for RADIUS MICRO SNARE, manufactured by Radius Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K022201 · Radius Medical Technologies, Inc. · Cardiovascular device
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Feb 2003
Decision
213d
Days
Class 2
Risk

K022201 is an FDA 510(k) clearance for the RADIUS MICRO SNARE. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Radius Medical Technologies, Inc. (Hopkonton, US). The FDA issued a Cleared decision on February 3, 2003 after a review of 213 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Radius Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K022201

510(k) Number K022201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2002
Decision Date February 03, 2003
Days to Decision 213 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
88d slower than avg
Panel avg: 125d · This submission: 213d
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 K022201.
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