Identity
- Trade Name
- Stedi™ FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- GUIDEWIRE STEDI-3 COMM US 10L FDA UDI
- Model / Reference
- STEDI-3 FDA UDI
- Description
- GUIDEWIRE STEDI-3 COMM US 10L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20763000978659 FDA UDI
- 510(k) Number
- K250075 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
No
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 — 0.035 Inch FDA UDILength — 275.0 Centimeter FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
Stedi™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac/peripheral vascular guidewire, single-use.
- INT, FirstWire — Shanghai Kindly Medical Instruments Co., Ltd. · Class II
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- HI-TORQUE BALANCE MIDDLEWEIGHT ELITE — Abbott Vascular · Class II
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL — Abbott Vascular · Class II
- JUDO™ 1 — Boston Scientific · Class II
Cleared under the same submission
K250075 also covers:
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 b2337ed3-2c0c-4fa2-a13c-556335517962 37 fields · synced May 30, 2026