The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Caracell.
| Device ID | K953118 |
| 510k Number | K953118 |
| Device Name: | CARACELL |
| Classification | Apparatus, Autotransfusion |
| Applicant | MEDTRONIC VASCULAR 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Contact | Kenneth E Imler |
| Correspondent | Kenneth E Imler MEDTRONIC VASCULAR 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1996-02-23 |