Identifiers
- 510(k) Number
- K964966 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
V-CATH is a percutaneous introducer kit. It is a device used for vascular access procedures.
The device is manufactured by Hdc Corp. and has received FDA 510(k) clearance under K964966. It is supplied as a kit for clinical use in general hospital settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: V-CATH PERCUTANEOUS INTRODUCER KIT (K951384) — FDA 510(k) | Innolitics, V-cath Picc (Peripherally Inserted Central Catheter), Hdc Corp. - 29 FDA 510 (k) Cleared Devices (Since 1983), V-CATH PERCUTANEOUS INTRODUCER KIT 510(k) K951384 - FDA.report, 510(k) Premarket Notification
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964966 | Class II | Active |
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Manufacturer
- Manufacturer
- Hdc Corp.
Sources (1)
- FDA 510(k) K964966 24 fields · synced Sep 23, 2026