Cleared Special

Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter

K142565 · Stryker Neurovascular · Cardiovascular
Nov 2014
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K142565 is an FDA 510(k) clearance for the Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on November 14, 2014, 63 days after receiving the submission on September 12, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K142565 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2014
Decision Date November 14, 2014
Days to Decision 63 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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