The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Acttrac Electronic Control Device For The Act & Act Ii Coagulation Instruments.
| Device ID | K953870 |
| 510k Number | K953870 |
| Device Name: | ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS |
| Classification | Timer, Clot, Automated |
| Applicant | MEDTRONIC VASCULAR 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Contact | James M Lumpkin |
| Correspondent | James M Lumpkin MEDTRONIC VASCULAR 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Product Code | GKN |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-17 |
| Decision Date | 1995-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994495167 | K953870 | 000 |
| 00763000135461 | K953870 | 000 |