Cleared Traditional

Needle Free Transseptal Cannula

K172934 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Feb 2018
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K172934 is an FDA 510(k) clearance for the Needle Free Transseptal Cannula, 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 16, 2018, 144 days after receiving the submission on September 25, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K172934 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2017
Decision Date February 16, 2018
Days to Decision 144 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

Similar Devices — DRC Trocar

All 50
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · Synaptic Medical Corporation · Jul 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · Pressure Products Medical Device Manufacturing, LLC · May 2024
SafeSept? Transseptal Guidewire (SS-140)
K221707 · Pressure Products Medical Device Manufacturing, LLC · Sep 2022
PathBuilder Transseptal Needle
K212625 · Shanghai Microport EP Medtech Co., Ltd. · Mar 2022
SafeSept Blunt Needle
K210328 · Pressure Products Medical Device Manufacturing, LLC · Mar 2021
TSN Transseptal Needle
K172950 · Pressure Products Medical Device Manufacturing, LLC · Feb 2018