Aspira Pleural Drainage System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110409 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)
The Aspira Pleural Drainage System is an apparatus for suction in patient care, classified as a class 2 device. It is used for pleural drainage.
The system is supplied with regulatory authorizations, including FDA 510K clearance. It is classified under the regulation number 870.5050 and has a product code of DWM. The device is manufactured by C.R. Bard, Inc. and has been found to be substantially equivalent.
Frequently asked questions
What is the Aspira Pleural Drainage System used for?
The Aspira Pleural Drainage System is used for pleural drainage in patient care, providing suction to remove fluid from the pleural space.
Is the Aspira Pleural Drainage System a single-use or reusable device?
The device data does not specify whether the Aspira Pleural Drainage System is single-use or reusable, but it is classified as a class 2 device.
What regulatory authorizations does the Aspira Pleural Drainage System have?
The Aspira Pleural Drainage System has FDA 510K clearance, indicating it has been found to be substantially equivalent to a predicate device.
What product code does the Aspira Pleural Drainage System have?
The Aspira Pleural Drainage System has a product code of DWM, which is classified under the regulation number 870.5050.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110409 | 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) K110409 24 fields · synced Sep 23, 2026