Cleared Traditional

K171268 - Reverse 021 Micro Catheter

K171268 is the FDA 510(k) clearance for Reverse 021 Micro Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K171268 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Cardiovascular device
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May 2017
Decision
30d
Days
Class 2
Risk

K171268 is an FDA 510(k) clearance for the Reverse 021 Micro Catheter, Reverse 027 Micro Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on May 31, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. d/b/a ev3 Neurovascular devices

Submission Details

510(k) Number K171268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2017
Decision Date May 31, 2017
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 506
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K171268.
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