preCARDIA Occlusion System

FDA 510(k) K221294 · Abiomed, Inc.

Unknown

510(k) numberK221294

Submission

Device name
preCARDIA Occlusion System
Applicant
Abiomed, Inc.
Danvers, MA, US
Received
May 4, 2022
Decision date
June 30, 2023
Decision
Unknown (SESU)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MJN – Catheter, Intravascular Occluding, Temporary
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

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K201652COBRA-OS KitMJN · Traditional Front Line Medical Technologies, Inc.02/22/2021SESK
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Questions and answers

When was preCARDIA Occlusion System cleared by the FDA?

preCARDIA Occlusion System (K221294) received a 510(k) decision of Unknown on June 30, 2023, 422 days after the submission was received.

What is the product code of K221294?

The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.