MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
FDA 510(k) clearance K041338 · decided 2004-07-19
Clearance details
- K-number
- K041338
- Device name
- MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2004-05-20
- Decision date
- 2004-07-19
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- MWS
- Device class
- 1
- Regulation number
- 870.4500
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Brooklyn Park, MN, 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 |
|---|---|---|
| PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (K992476) | Pilling Weck Surgical | 2000-09-13 |
| VACUUM ASSIST STABILIZER (K992833) | Cardio Thoracic Systems | 1999-11-10 |
| HEART-LIFT BALLOON POSITIONER (K982419) | Cardiothoracic Systems, Inc. | 1999-01-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| 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 |