Identity
- Trade Name
- Adelante Radial FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Introducer Set with Hemostatic Valve, 4F FDA UDI
- Model / Reference
- ASR04010P FDA UDI
- Description
- Introducer Set with Hemostatic Valve, 4F FDA UDI
Identifiers
- Catalog Number
- ASR04010P FDA UDI
- Primary DI / UDI-DI
- 20885672000480 FDA UDI
- 510(k) Number
- K130633 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 1.5 Millimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Adelante Radial by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130633 also covers:
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor Inc.
- Adelante Radial — Oscor 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
- Oscor Inc.
Sources (1)
- FDA UDI 49d82ca8-e94d-4055-aacc-3cd152f6af9c 38 fields · synced May 30, 2026