Cleared Traditional

K990487 - EQUINOX OCCLUSION BALLOON SYSTEM

K990487 is an FDA 510(k) clearance for EQUINOX OCCLUSION BALLOON SYSTEM, 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 196-day FDA review.

K990487 · Micro Therapeutics, Inc. · Cardiovascular device
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Aug 1999
Decision
196d
Days
Class 2
Risk

K990487 is an FDA 510(k) clearance for the EQUINOX 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 August 31, 1999 after a review of 196 days - an extended review 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: 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 Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K990487

510(k) Number K990487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 16, 1999
Decision Date August 31, 1999
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 K990487.
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
K001237 · Micro Therapeutics, Inc. · May 2000
LEMAITRE OCCLUSION CATHETER
K992942 · Vascutech, Inc. · Apr 2000
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
K993292 · Boston Scientific, Target · Mar 2000
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
K983802 · Lucas Medical, Inc. · Jul 1999
TEMPORARY OCCLUSION BALLOON SYSTEM
K972777 · Percu Surge, Inc. · Mar 1998
CHASE VESSEL OCCLUDER
K964390 · Chase Medical, Inc. · Jan 1997