Bard Umbilical Vessel Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K890685 FDA 510(k)
- FDA Product Code
- FOS 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)
The Bard Umbilical Vessel Catheter is a Class 2 medical device designed for use in general hospital settings. It is a catheter specifically intended for umbilical vessel access and procedures.
This device is manufactured by C.R. Bard, Inc. and is supplied as a single-use or reusable product, though sterility information is not specified. It received FDA 510(k) clearance on February 28, 1989, with the K number K890685, and is regulated under product code FOS with regulation number 880.5200.
Frequently asked questions
What is the Bard Umbilical Vessel Catheter used for?
The Bard Umbilical Vessel Catheter is designed for umbilical vessel access and procedures in general hospital settings. It is a Class 2 medical device intended for specific vascular access applications in neonatal care.
Is the Bard Umbilical Vessel Catheter single-use or reusable?
The Bard Umbilical Vessel Catheter is supplied as either a single-use or reusable product, though the specific sterility information is not detailed in the available documentation. Users should follow the manufacturer's instructions for proper handling and disposal.
What regulatory approvals does the Bard Umbilical Vessel Catheter have?
The Bard Umbilical Vessel Catheter received FDA 510(k) clearance on February 28, 1989, with K number K890685. It is regulated under product code FOS with regulation number 880.5200 and is classified as a Class 2 medical device.
What sizes and models of the Bard Umbilical Vessel Catheter are available?
The available specifications regarding sizes and models of the Bard Umbilical Vessel Catheter are not detailed in the provided device data. For specific sizing information and model options, users should consult the manufacturer directly or refer to the product documentation.
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: BARD UMBILICAL VESSEL CATHETER (K890685) — FDA 510 (k) | Innolitics, K890685 - BARD UMBILICAL VESSEL CATHETER | FDA 510 (k), PDF K890685 - Bard Umbilical Vessel Catheter, Bard Umbilical Vessel Catheter - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890685 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K890685 24 fields · synced Sep 25, 2026