Cleared Traditional

Liverty? TIPS Access Set

K221440 · Bard Peripheral Vascular, Inc. · Cardiovascular
May 2022
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K221440 is an FDA 510(k) clearance for the Liverty? TIPS Access Set, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on May 31, 2022, 14 days after receiving the submission on May 17, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K221440 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2022
Decision Date May 31, 2022
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340