The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Baylor Rapid Autotransfusion System.
| Device ID | K852736 |
| 510k Number | K852736 |
| Device Name: | BAYLOR RAPID AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | CARDIO SYSTEMS, INC. 1610 WOODSTEAD COURT, SU 430 The Woodlands, TX 77380 |
| Contact | Don E Spyrison |
| Correspondent | Don E Spyrison CARDIO SYSTEMS, INC. 1610 WOODSTEAD COURT, SU 430 The Woodlands, TX 77380 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-08 |
| Decision Date | 1985-09-18 |