Cleared Traditional

PM2+ System and SmartPICC Stylet

K243484 · Piccolo Medical, Inc. · Cardiovascular
May 2025
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K243484 is an FDA 510(k) clearance for the PM2+ System and SmartPICC Stylet, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Piccolo Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on May 29, 2025, 202 days after receiving the submission on November 8, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K243484 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2024
Decision Date May 29, 2025
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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