Cleared Special

SafeSept? Transseptal Guidewire (SS-140)

K221707 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Sep 2022
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K221707 is an FDA 510(k) clearance for the SafeSept? Transseptal Guidewire (SS-140), 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 September 14, 2022, 93 days after receiving the submission on June 13, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K221707 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2022
Decision Date September 14, 2022
Days to Decision 93 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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