Cleared Special

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

K241042 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
May 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241042 is an FDA 510(k) clearance for the SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198), 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 May 17, 2024, 30 days after receiving the submission on April 17, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K241042 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2024
Decision Date May 17, 2024
Days to Decision 30 days
Submission Type Special
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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