The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Intraoperative Autotransfusion Sys.
| Device ID | K831557 |
| 510k Number | K831557 |
| Device Name: | INTRAOPERATIVE AUTOTRANSFUSION SYS |
| Classification | Apparatus, Autotransfusion |
| Applicant | THORATEC LABORATORIES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-08-24 |