Cleared Special

K011656 - HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771

K011656 is an FDA 510(k) clearance for HYPERFORM OCCLUSION BALLOON SYSTEM, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Special 510(k) pathway after a 22-day FDA review.

K011656 · Micro Therapeutics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2001
Decision
22d
Days
Class 2
Risk

K011656 is an FDA 510(k) clearance for the HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771. 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 20, 2001 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K011656

510(k) Number K011656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date June 20, 2001
Days to Decision 22 days
Submission Type Special
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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 K011656.
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
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
K021066 · Micro Therapeutics, Inc. · Jun 2002
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · Micro Therapeutics, Inc. · Aug 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
K011526 · Micro Therapeutics, Inc. · Jun 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
K010162 · Micro Therapeutics, Inc. · May 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320 · NuMED, Inc. · May 2001