Cleared Traditional

K021066 - MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM

K021066 is an FDA 510(k) clearance for MODIFICATION TO HYPERGLIDE OCCLUSION BA..., manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K021066 · Micro Therapeutics, Inc. · Cardiovascular device
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Jun 2002
Decision
77d
Days
Class 2
Risk

K021066 is an FDA 510(k) clearance for the MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on June 18, 2002 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K021066

510(k) Number K021066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date June 18, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 71
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K021066.
NUMED PTS X SIZING BALLOON CATHETER
K041306 · NuMED, Inc. · Jun 2004
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
K031357 · Possis Medical, Inc. · May 2004
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
K033159 · LeMaitre Vascular, Inc. · Dec 2003
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · Micro Therapeutics, Inc. · Aug 2001
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656 · Micro Therapeutics, Inc. · Jun 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
K011526 · Micro Therapeutics, Inc. · Jun 2001