CentriMag Acute Circulatory Support System
FDA 510(k) K234118 · Abbott Medical
510(k) numberK234118
Submission
- Device name
- CentriMag Acute Circulatory Support System
- Applicant
- Abbott Medical
Pleasanton, CA, US - Received
- December 28, 2023
- Decision date
- January 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNR – Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected…
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Questions and answers
When was CentriMag Acute Circulatory Support System cleared by the FDA?
CentriMag Acute Circulatory Support System (K234118) received a 510(k) decision of Substantially Equivalent on January 26, 2024, 29 days after the submission was received.
What is the product code of K234118?
The FDA product code is QNR – Blood Pump For Ecmo, Long-Term (> 6 Hours) Use, a Class II (moderate risk) device regulated under 21 CFR 870.4100.