Cleared Special

SSPC NXT Delivery Catheter

K243180 · CenterPoint Systems, LLC · Cardiovascular
Dec 2024
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K243180 is an FDA 510(k) clearance for the SSPC NXT Delivery Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on December 4, 2024, 65 days after receiving the submission on September 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K243180 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date December 04, 2024
Days to Decision 65 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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