Cleared Traditional

PM2 System and ECGuide Connector

K240486 · Piccolo Medical, Inc. · Cardiovascular
Sep 2024
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K240486 is an FDA 510(k) clearance for the PM2 System and ECGuide Connector, 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 September 8, 2024, 201 days after receiving the submission on February 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K240486 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2024
Decision Date September 08, 2024
Days to Decision 201 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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