Identity
- Trade Name
- Vessel Dilator FDA UDI
- Generic Name
- Fascial tissue dilator, single-use FDA UDI
- Device Name
- Vessel Dilator 7 French FDA UDI
- Model / Reference
- 392306 FDA UDI
- Description
- Vessel Dilator 7 French FDA UDI
Identifiers
- Catalog Number
- 392306 FDA UDI
- Primary DI / UDI-DI
- 00886333210381 FDA UDI
- 510(k) Number
- K780126 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Fascial tissue dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 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
Category: Fascial tissue dilator, single-use
Vessel Dilator by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fascial tissue dilator, single-use.
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- Dilator — GALT MEDICAL CORP. · Class IIa
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
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 bf9ef3a2-1623-4037-adaf-4a4f5bc6c7be 37 fields · synced Jun 9, 2026