Identity
- Trade Name
- 5F Axcess Percutaneous Catheter Introducer Kit FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- 5F Axcess Percutaneous Catheter Introducer Kit FDA UDI
- Model / Reference
- 496035 FDA UDI
- Description
- 5F Axcess Percutaneous Catheter Introducer Kit FDA UDI
Identifiers
- Catalog Number
- 496035 FDA UDI
- Primary DI / UDI-DI
- 00886333213375 FDA UDI
- 510(k) Number
- K780126 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
5F Axcess Percutaneous Catheter Introducer Kit by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K780126 also covers:
- Axcess Percutaneous Introducer — Argon Medical Devices, Inc.
- Axcess Percutaneous Introducer — Argon Medical Devices, Inc.
- ClosureFast Introducer Sheath — Argon Medical Devices, Inc.
- ClosureFast™ Micro Introducer Sheath Set — Argon Medical Devices, Inc.
- Introducer Kits — Argon Medical Devices, Inc.
- MicroStic Plus — Argon Medical Devices, Inc.
- One-Piece Introducer Tray — Argon Medical Devices, Inc.
- One-Piece Introducer Tray — Argon Medical Devices, Inc.
- One-Piece/Tuohy-Borst Introducer Tray — Argon Medical Devices, Inc.
- One-Piece/Tuohy-Borst Introducer Tray — Argon Medical Devices, Inc.
- One-Piece/Tuohy-Borst Introducer Tray — Argon Medical Devices, Inc.
- OneStic Micro-Access Introducer — Argon Medical Devices, 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
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 7efea547-e374-4e7e-9f78-42cb511ad835 38 fields · synced Jun 9, 2026