Cleared Special

Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter

K242289 · Stryker Neurovascular · Neurology

Mar 2025

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K242289 is an FDA 510(k) clearance for the Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on March 21, 2025, 231 days after receiving the submission on August 2, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242289 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2024
Decision Date	March 21, 2025
Days to Decision	231 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures