Sarns 9000 Perfusion System W/Alert Only Level
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K900815 FDA 510(k)
- FDA Product Code
- DTW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4340 FDA 510(k)
- Regulation Number
- 870.4340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sarns 9000 Perfusion System with Alert Only Level is a Monitor and/or Control, Level Sensing device designed for cardiopulmonary bypass procedures. It functions as part of an extracorporeal circulation system, ensuring precise regulation of fluid levels during surgical interventions requiring controlled blood perfusion, such as open-heart surgery or regional perfusion.
This device is intended for single-use in clinical settings and is regulated under FDA 510(k) clearance (K900815) as a Class II medical device under product code DTW. Supplied sterile, it operates within the context of cardiopulmonary support systems and adheres to Special Controls for cardiovascular applications. No MRI safety or reusable specifications are indicated in the regulatory data.
Frequently asked questions
What is the Sarns 9000 Perfusion System (Alert Level) used for?
The Sarns 9000 Perfusion System with Alert Only Level is designed specifically for cardiopulmonary bypass procedures. It monitors and controls fluid levels within an extracorporeal circulation system to maintain precise perfusion during surgeries like open-heart procedures or regional perfusion. This ensures stable blood flow and oxygenation during critical interventions.
Is the Sarns 9000 Perfusion System (Alert Level) intended for single-use or reuse?
This device is intended for single-use only in clinical settings. It is supplied sterile and is not designed for reprocessing or reuse, which helps maintain patient safety and device performance during critical surgical procedures.
What regulatory clearance does the Sarns 9000 Perfusion System (Alert Level) hold?
The Sarns 9000 Perfusion System with Alert Only Level holds FDA 510(k) clearance (K900815) as a Class II medical device under product code DTW. It is classified under Special Controls for cardiovascular applications and is intended for use in cardiopulmonary support systems.
How is the Sarns 9000 Perfusion System (Alert Level) supplied?
The device is supplied sterile and packaged for single-use. It is not intended for reuse or reprocessing, ensuring compliance with clinical infection control protocols during cardiopulmonary bypass procedures.
Does the Sarns 9000 Perfusion System (Alert Level) have any MRI safety considerations?
The regulatory data for this device does not specify any MRI safety information. Clinicians should follow standard MRI safety protocols when using this device in proximity to MRI environments, as extracorporeal circulation systems may interact with magnetic fields.
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: K900815 - Sarns 9000 Perfusion System W/Alert Onl..., SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (K900815) — FDA 510(k ..., Sarns 9000 Perfusion System W/Alert Only Level, Perfusion Products : Products : Terumo Cardiovascular Systems, PDF Terumo Sarns 9000 Heart Lung Machine - Soma Tech Intl
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900815 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K900815 24 fields · synced Oct 1, 2026