Identifiers
- 510(k) Number
- K904040 FDA 510(k)
- FDA Product Code
- DTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4400 FDA 510(k)
- Regulation Number
- 870.4400 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Softshell Venous Reservoir is a reservoir used in cardiopulmonary bypass procedures. It is classified as a class 2 device. The device is used in cardiovascular applications.
The Softshell Venous Reservoir is supplied with a product code of DTN and has an FDA 510K authorization. The device has a regulation number of 870.4400 and is registered with the FDA with the registration number 3030125051, among others. The device is manufactured by C.R. Bard, Inc.
Frequently asked questions
What is the Softshell Venous Reservoir used for?
The Softshell Venous Reservoir is used in cardiopulmonary bypass procedures, specifically in cardiovascular applications.
Is the Softshell Venous Reservoir a single-use or reusable device?
The device data does not specify whether the Softshell Venous Reservoir is single-use or reusable, but it is typically used in a clinical setting where sterility and safety protocols are followed.
What is the regulatory classification of the Softshell Venous Reservoir?
The Softshell Venous Reservoir is classified as a class 2 device with a regulation number of 870.4400 and has an FDA 510K authorization.
Who manufactures the Softshell Venous Reservoir?
The Softshell Venous Reservoir is manufactured by C.R. Bard, Inc.
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: SOFTSHELL VENOUS RESERVOIR (K904040) - FDA 510 (k), SOFTSHELL VENOUS RESERVOIR (K904040) — FDA 510(k) | Innolitics, Softshell Venous Reservoir 510 (k) K904040 - FDA.report, PDF K904040 - Softshell Venous Reservoir, 510 (k) K904040 — SOFTSHELL VENOUS RESERVOIR — RegDataLab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904040 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K904040 24 fields · synced Sep 25, 2026