Identity
- Trade Name
- Adelante Sigma FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Introducer Set with Hemostatic Valve, 4F FDA UDI
- Model / Reference
- ASG0401035 FDA UDI
- Description
- Introducer Set with Hemostatic Valve, 4F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885672001688 FDA UDI
- 510(k) Number
- K090114 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 — 1.4 Millimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Adelante Sigma by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K090114 also covers:
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — Oscor Inc.
- Adelante Sigma — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oscor Inc.
Sources (1)
- FDA UDI 675da86a-19c7-40c5-9fd8-4da466dbcefe 37 fields · synced Jun 8, 2026