Cleared Traditional

TSI Transseptal Introducer

K181031 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Oct 2018
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K181031 is an FDA 510(k) clearance for the TSI Transseptal Introducer, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on October 26, 2018, 191 days after receiving the submission on April 18, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K181031 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2018
Decision Date October 26, 2018
Days to Decision 191 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