Cleared Special

AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &

K133625 · Codman & Shurtleff, Inc. · Neurology
Feb 2014
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K133625 is an FDA 510(k) clearance for the AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on February 24, 2014, 90 days after receiving the submission on November 26, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K133625 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2013
Decision Date February 24, 2014
Days to Decision 90 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MOF — Guide, Wire, Catheter, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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