MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
FDA 510(k) clearance K022238 · decided 2002-10-09
Clearance details
- K-number
- K022238
- Device name
- MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2002-07-11
- Decision date
- 2002-10-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DWS
- Device class
- 1
- Regulation number
- 870.4500
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
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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 |