Cleared Traditional

HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS (K101570) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101570 · Micro Therapeutics Dba Ev3 Neurovascular · Cardiovascular device
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Jul 2010
Decision
39d
Days
Class 2
Risk

K101570 is an FDA 510(k) clearance for the HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Micro Therapeutics Dba Ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on July 13, 2010 after a review of 39 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 Dba Ev3 Neurovascular devices

Submission Details

510(k) Number K101570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date July 13, 2010
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 89
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