Cleared Special

SafeSept Blunt Needle

K210328 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Mar 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K210328 is an FDA 510(k) clearance for the SafeSept Blunt 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 March 5, 2021, 29 days after receiving the submission on February 4, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K210328 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2021
Decision Date March 05, 2021
Days to Decision 29 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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