The following data is part of a premarket notification filed by Cardiacassist Inc with the FDA for Lifesparc Pump, Lifesparc Controller.
| Device ID | K183623 |
| 510k Number | K183623 |
| Device Name: | LifeSPARC Pump, LifeSPARC Controller |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | CardiacAssist Inc 620 Alpha Drive Pittsburgh, PA 15238 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CardiacAssist Inc 620 Alpha Drive Pittsburgh, PA 15238 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020654 | K183623 | 000 |
| 00814112020647 | K183623 | 000 |
| 00814112020579 | K183623 | 000 |
| 00814112020562 | K183623 | 000 |
| 00814112020906 | K183623 | 000 |
| 00814112020586 | K183623 | 000 |