Identity
- Trade Name
- DxTerity™ TRA Angio-Kit FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- CATH AKUNIV602 DXT 6F 5PK ANGIO RAD KIT FDA UDI
- Model / Reference
- AKUNIV602 FDA UDI
- Description
- CATH AKUNIV602 DXT 6F 5PK ANGIO RAD KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169738362 FDA UDI
- 510(k) Number
- K161287 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Angiographic catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
- Catheter Gauge — 6.0 French FDA UDI
Category: Angiographic catheter, single-use
DxTerity™ TRA Angio-Kit by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiographic catheter, single-use.
- INFINITI — Cordis US Corp. · Class II
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- Torcon NB — COOK INCORPORATED · Class II
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- INFINITI — Cordis US Corp. · Class II
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Cleared under the same submission
K161287 also covers:
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — MEDTRONIC, INC.
- DxTerity™ — 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 2f9e4631-95cb-42f5-8d92-5de09cd9b110 37 fields · synced Jun 1, 2026