Cleared Special

AXS Infinity LS Plus Long Sheath

K193034 · Stryker Neurovascular · Neurology
Nov 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K193034 is an FDA 510(k) clearance for the AXS Infinity LS Plus Long Sheath, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on November 29, 2019, 29 days after receiving the submission on October 31, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K193034 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2019
Decision Date November 29, 2019
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
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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