Identity
- Trade Name
- V-Cath FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- 4.0Fr x 10cm Tearaway Sheath Dilator Introducer Set FDA UDI
- Model / Reference
- 4053-003 FDA UDI
- Description
- 4.0Fr x 10cm Tearaway Sheath Dilator Introducer Set FDA UDI
Identifiers
- Catalog Number
- 4053-003 FDA UDI
- Primary DI / UDI-DI
- B33940530030 FDA UDI
- 510(k) Number
- K951384 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 10.0 Centimeter FDA UDICatheter Gauge — 4.0 French FDA UDI
Category: Vascular catheter introduction set, nonimplantable
V-Cath by Neo Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K951384 also covers:
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- NeoMagic — Neo Medical Inc.
- V-Cath — Neo Medical Inc.
- V-Cath — Neo Medical 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
- Neo Medical Inc.
Sources (1)
- FDA UDI d8ddcb96-5f28-4829-9846-1bc66632db93 38 fields · synced May 30, 2026