510(k) K234118
- Device
- CentriMag? Acute Circulatory Support System
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K234118
- Product code
- QNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-26
- Date received
- 2023-12-28
- Regulation
- 870.4100
- Classification name
- Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bendre Ketaki
- Address
- 6035 Stoneridge Dr. Pleasanton Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 3011468686
- 3010163695
- 9617601
- 3003306248
- 2133810
- 1218444
- 2916596
- 9611665
- 3004593495
Source Documents#
Other 510(k) Records For Product Code QNR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250199 | VitalFlow Console | Medtronic, Inc. | 2025-05-20 |
| K233736 | LifeSPARC System | Cardiacassist, Inc. | 2024-01-19 |
| K223898 | VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| K230364 | VitalFlow™ Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| K222038 | CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System | Abbott (Formerly Thoratec Corporation) | 2022-12-08 |
| K211830 | LifeSPARC System | Cardiacassist, Inc. | 2022-11-15 |
| K202751 | TandemHeart Pump and Escort Controller | Cardiacassist, Inc. | 2021-03-26 |