Cleared Traditional

K021066 - MODIFICATION TO HYPERGLIDE OCCLUSION BA...

K021066 is the FDA 510(k) clearance for MODIFICATION TO HYPERGLIDE OCCLUSION BA... by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 29
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K021066.
SCEPTER C OCCLUSION BALLOON CATHETER
K110741 · MicroVention, Inc. · Sep 2011
FOGARTY OCCLUSION CATHETER
K093911 · Edwards Lifesciences, LLC · Jan 2010
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · Micro Therapeutics, Inc. · Aug 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · Cook, Inc. · Mar 2001