Identity
- Trade Name
- Angiographic Guide Wire FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- WIRE ANG 008944 10PK .035INX175CM 1.5MMJ FDA UDI
- Model / Reference
- 008944 FDA UDI
- Description
- WIRE ANG 008944 10PK .035INX175CM 1.5MMJ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169857186 FDA UDI
- 510(k) Number
- K082873 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
- Outer Diameter — 0.889 Millimeter FDA UDILength — 175.0 Centimeter FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
Angiographic Guide Wire 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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- Forté™ — Lake Region Medical · Class II
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- HI-TORQUE BALANCE MIDDLEWEIGHT ELITE — Abbott Vascular · Class II
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- JUDO™ 1 — Boston Scientific · Class II
Cleared under the same submission
K082873 also covers:
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — MEDTRONIC, INC.
- Angiographic Guide Wire — 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 d23ab839-f45d-47e7-8975-c724aa7b64b1 36 fields · synced May 30, 2026