Cleared Traditional

K171268 - Reverse 021 Micro Catheter, Reverse 027 Micro Catheter

K171268 is an FDA 510(k) clearance for Reverse 021 Micro Catheter, manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K171268

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
Combination Product No
PCCP Authorized No
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.

DQY Device Classification - Class 2, Special Controls

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 687
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K171268.
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
K171146 · Arrow International, Inc. (Subsidiary of Telelflex Inc.) · Jun 2017
Wingman 14C Crossing Catheter
K170996 · Reflow Medical, Inc. · Jun 2017
Venture 038 catheter
K171335 · Vascular Solutions, Inc. · Jun 2017
Guidezilla II Guide Extension Catheter
K163314 · Boston Scientific Corporation · Mar 2017
CenterCross Ultra LV Catheter
K170403 · Roxwood Medical, Inc. · Mar 2017
TrapLiner catheter
K161901 · Vascular Solutions, Inc. · Feb 2017