William Harvey Vented Mediastinal Drain
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K803037 FDA 510(k)
- FDA Product Code
- DWM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5050 FDA 510(k)
- Regulation Number
- 870.5050 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an apparatus for suction in patient care, specifically a vented mediastinal drain. It is classified under medical specialty cardiovascular and has the product code DWM.
It received FDA 510(k) clearance K803037 on February 4, 1981, as substantially equivalent to a predicate device. The clearance is traditional type, and the device is not third-party reviewed. Regulation number is 870.5050.
Frequently asked questions
What is the William Harvey Vented Mediastinal Drain used for?
This device is an apparatus for suction in patient care, specifically designed as a vented mediastinal drain to remove fluids or air from the mediastinal space following cardiovascular or thoracic procedures.
How is the William Harvey Vented Mediastinal Drain supplied and is it reusable?
The device data does not specify whether the drain is supplied sterile, single-use, or reusable; therefore, no conclusion can be drawn about its supply format or reusability from the provided information.
What regulatory pathway was used for the William Harvey Vented Mediastinal Drain?
The device received FDA 510(k) clearance K803037 on February 4, 1981, as substantially equivalent to a predicate device, through a traditional 510(k) submission process.
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: WILLIAM HARVEY VENTED MEDIASTINAL DRAIN (K803037) — FDA 510 (k ..., William Harvey Vented Mediastinal Drain 510(k) K803037 - fda.report, PDF K803037 - William Harvey Vented Mediastinal Drain, HARVEY v. C. R. BARD, INC. (2:25-cv-00616), New Jersey District Court
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K803037 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K803037 24 fields · synced Sep 25, 2026