Cleared Traditional

pNOVUS 21 Microcatheter

K221279 · Phenox, Ltd. · Neurology

Nov 2022

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K221279 is an FDA 510(k) clearance for the pNOVUS 21 Microcatheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Phenox, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 28, 2022, 209 days after receiving the submission on May 3, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K221279 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2022
Decision Date	November 28, 2022
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF