Cleared Traditional

HYBRID Guidewire

K182337 · Balt USA, LLC · Neurology
Oct 2018
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K182337 is an FDA 510(k) clearance for the HYBRID Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on October 4, 2018, 37 days after receiving the submission on August 28, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K182337 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2018
Decision Date October 04, 2018
Days to Decision 37 days
Submission Type Traditional
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