Cleared Traditional

preCARDIA Occlusion System

K221294 · Abiomed, Inc. · Cardiovascular
Jun 2023
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K221294 is an FDA 510(k) clearance for the preCARDIA Occlusion System, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on June 30, 2023, 422 days after receiving the submission on May 4, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K221294 FDA.gov
FDA Decision Cleared SESU
Date Received May 04, 2022
Decision Date June 30, 2023
Days to Decision 422 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MJN — Catheter, Intravascular Occluding, Temporary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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