Cleared Traditional

SafeSept Needle Free Transseptal Guidewire

K172893 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Dec 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K172893 is an FDA 510(k) clearance for the SafeSept Needle Free Transseptal Guidewire, 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 December 21, 2017, 90 days after receiving the submission on September 22, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K172893 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2017
Decision Date December 21, 2017
Days to Decision 90 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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