SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
FDA 510(k) clearance K103095 · decided 2010-10-22
Clearance details
- K-number
- K103095
- Device name
- SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
- Applicant
- Medtronic, Ireland
- Decision
- Substantially Equivalent
- Date received
- 2010-10-08
- Decision date
- 2010-10-22
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Rosa, CA, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Integrity Coronary Stent Systems (P030009/S101) | Medtronic, Ireland | 2022-07-15 |
| Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System (P030009/S107) | Medtronic, Ireland | 2022-04-19 |
| Integrity Coronary Stent System (P030009/S104) | Medtronic, Ireland | 2022-01-27 |
| Integrity Coronary Stent System RX and OTW (P030009/S105) | Medtronic, Ireland | 2021-12-14 |
| Integrity Coronary Stent System Rx and OTW (P030009/S106) | Medtronic, Ireland | 2021-11-16 |
| Integrity Coronary Stent System Rx and OTW (P030009/S103) | Medtronic, Ireland | 2021-05-21 |
| Integrity Coronary Stent System (hereafter called Integrity) (P030009/S102) | Medtronic, Ireland | 2021-05-11 |
| Integrity Coronary Stent System (P030009/S100) | Medtronic, Ireland | 2021-03-12 |