ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
FDA 510(k) clearance K953870 · decided 1995-10-31
Clearance details
- K-number
- K953870
- Device name
- ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 1995-08-17
- Decision date
- 1995-10-31
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GKN
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parker, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (K940426) | Medtronic Hemotec, Inc. | 1994-09-20 |
| MIL CM-II COAGULATION MACHINE (K913320) | Medical Innovations Corp. | 1992-06-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
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| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |