LifeSPARC
LifeSPARC Blood Pump Kit with 72cm Transseptal Cannula and 15Fr Arterial Cannula
1manufacturer
9catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Cardiacassist, Inc., United States |
|---|---|
| FDA product code | KRI |
| Device type | Accessory Equipment, Cardiopulmonary Bypass |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4200 |
| 510(k) | K153295 |
| Record published | 2019-12-18 |
| Record revised | 2024-12-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-12-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5150-0006 | Withdrawn | |
| 5810-7215 | Withdrawn | |
| 5810-6215 | Withdrawn | |
| 5800-0000 | Withdrawn | |
| 5800-1000 | Withdrawn | |
| 5150-0005 | Withdrawn | |
| 5810-7217 | Withdrawn | |
| 5800-1001 | Withdrawn | |
| 5810-6217 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bracket | LivaNova USA, Inc. | 16 |
| Accessory Equipment, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 15 |
| VivaCart | CardioQuip | 14 |
| Capiox | Terumo Corp. | 12 |
| CentriMag™ | Thoratec Corp. | 11 |
| Quantum | Spectrum Medical Ltd | 8 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 8 |
| Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 6 |
| Novatemp | Novamed-USA | 5 |
| Inspire | Sorin Group Italia SRL | 5 |
| Holder | Eurosets SRL | 4 |
| Forceps | LivaNova USA, Inc. | 4 |
Showing 12 of 108. All products under Accessory Equipment, Cardiopulmonary Bypass
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardiac Assist, Inc | 510(k) number | 2023-06-30 | Class II | Under Investigation by firm | Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure, | 2 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.