Identity
- Trade Name
- SPRINTER LEGEND FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- BLN SPL12510WL SPR LEGEND 1.25X10 OTW US FDA UDI
- Model / Reference
- SPL12510WL FDA UDI
- Description
- BLN SPL12510WL SPR LEGEND 1.25X10 OTW US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169018990 FDA UDI
- 510(k) Number
- K103095 FDA UDI
- FDA Product Code
- LOX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.25 Millimeter FDA UDILength — 10.0 Millimeter FDA UDI
Category: Coronary angioplasty balloon catheter, basic
Sprinter Legend by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, basic.
- REBEL™ — Boston Scientific · Class III
- Pantera Pro — Biotronik, Inc. · Class II
- Emerge™ — Boston Scientific · Class II
- AngioSculpt® PTCA Scoring Balloon Catheter — Angioscore, Inc. · Class III
- SC HONKYTONK — Sino Medical Sciences Technology Inc. · Class II
- OTW TAKERU — Kaneka Corp. · Class II
- NC ROCKSTAR — Sino Medical Sciences Technology Inc. · Class II
- Emerge™ — Boston Scientific · Class II
Cleared under the same submission
K103095 also covers:
- SPRINTER LEGEND — MEDTRONIC, INC.
- SPRINTER LEGEND — MEDTRONIC, INC.
- SPRINTER LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
- SPRINTER® LEGEND — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 6cb0254c-7e5d-4fc3-ac54-dc40f17bfce1 36 fields · synced Jun 8, 2026