COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
FDA 510(k) clearance K062264 · decided 2007-11-08
Clearance details
- K-number
- K062264
- Device name
- COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
- Applicant
- Medtronic Vascular
- Decision
- Unknown
- Date received
- 2006-08-04
- Decision date
- 2007-11-08
- Days to decision
- 461 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Rosa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code recall (Z-0654-2010) | Medtronic CardioVascular | 2010-01-19 |
| Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code recall (Z-0655-2010) | Medtronic CardioVascular | 2010-01-19 |
| Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a recall (Z-0642-2009) | Medtronic Cardiovascular | 2009-03-18 |
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 |