Identity
- Trade Name
- ProVia 12 FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- GDWR 12PROV180SS PROVIA 5PK 180 SI ST FDA UDI
- Model / Reference
- 12PROV180SS FDA UDI
- Description
- GDWR 12PROV180SS PROVIA 5PK 180 SI ST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000569785 FDA UDI
- 510(k) Number
- K140695 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
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
- Length — 180.0 Centimeter FDA UDIOuter Diameter — 0.014 Inch FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
ProVia 12 by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac/peripheral vascular guidewire, single-use.
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- JUDO™ 1 — Boston Scientific · Class II
Cleared under the same submission
K140695 also covers:
- COUGAR® LS — MEDTRONIC, INC.
- COUGAR® LS — MEDTRONIC, INC.
- COUGAR® LS — MEDTRONIC, INC.
- COUGAR® LS — MEDTRONIC, INC.
- COUGAR® LS — MEDTRONIC, INC.
- COUGAR® XT — MEDTRONIC, INC.
- COUGAR® XT — MEDTRONIC, INC.
- COUGAR® XT — MEDTRONIC, INC.
- COUGAR® XT — MEDTRONIC, INC.
- COUGAR® XT — MEDTRONIC, INC.
- Intuition — MEDTRONIC, INC.
- ProVia 12 — 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 5e95200a-6eb7-45d7-ad2e-141cb320b8c3 37 fields · synced May 31, 2026