Cleared Special

Phenom Catheters (K210230) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210230 · Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · Neurology device
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Feb 2021
Decision
28d
Days
Class 2
Risk

K210230 is an FDA 510(k) clearance for the Phenom Catheters. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on February 25, 2021 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device 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 Lnc. D/B/A Ev3 Neurovascular devices

Submission Details

510(k) Number K210230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2021
Decision Date February 25, 2021
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Neurology devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 318
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K210230.
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