Cleared Traditional

Ballast 088 Long Sheath

K182918 · Balt USA, LLC · Neurology
Mar 2019
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K182918 is an FDA 510(k) clearance for the Ballast 088 Long Sheath, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on March 21, 2019, 153 days after receiving the submission on October 19, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K182918 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2018
Decision Date March 21, 2019
Days to Decision 153 days
Submission Type Traditional
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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