CentriMag™ Blood Pump For Use With CentriMag™ Acute Circulatory Support System

Blood Pump For Ecmo, Long-term (> 6 Hours) Use

Abbott (formerly Thoratec Corporation)

The following data is part of a premarket notification filed by Abbott (formerly Thoratec Corporation) with the FDA for Centrimag™ Blood Pump For Use With Centrimag™ Acute Circulatory Support System.

Pre-market Notification Details

• Device ID: K222038
• 510k Number: K222038
• Device Name: CentriMag™ Blood Pump For Use With CentriMag™ Acute Circulatory Support System
• Classification: Blood Pump For Ecmo, Long-term (> 6 Hours) Use
• Applicant: Abbott (formerly Thoratec Corporation) 6035 Stoneridge Drive Pleasanton, CA 94588
• Contact: Meera Mehta
• Correspondent: Meera Mehta; Abbott (formerly Thoratec Corporation) 6035 Stoneridge Drive Pleasanton, CA 94588
• Product Code: QNR
• CFR Regulation Number: 870.4100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2022-07-11
• Decision Date: 2022-12-08