Cleared Traditional

Paragon 8F Balloon Guide Catheter

K232437 · Wallaby Medical · Neurology
Oct 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K232437 is an FDA 510(k) clearance for the Paragon 8F Balloon Guide Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on October 13, 2023, 60 days after receiving the submission on August 14, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K232437 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2023
Decision Date October 13, 2023
Days to Decision 60 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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