Cleared Traditional

TSN Transseptal Needle

K172950 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Feb 2018
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K172950 is an FDA 510(k) clearance for the TSN Transseptal Needle, a Trocar (Class II — Special Controls, product code DRC), submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on February 21, 2018, 148 days after receiving the submission on September 26, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K172950 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2017
Decision Date February 21, 2018
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRC — Trocar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1390

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