Identity
- Trade Name
- PCI Kit/4 Percutaneous Catheter Introducer FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- 4F Pediatric PCI Kit/4 Percutaneous Catheter Introducer FDA UDI
- Model / Reference
- 496166 FDA UDI
- Description
- 4F Pediatric PCI Kit/4 Percutaneous Catheter Introducer FDA UDI
Identifiers
- Catalog Number
- 496166 FDA UDI
- Primary DI / UDI-DI
- 00886333213771 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
PCI Kit/4 Percutaneous Catheter Introducer 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 950eeb87-f7da-4e53-8386-fbfab8f69385 38 fields · synced Jun 9, 2026