Cardiotomy Reservoirs
by Erik Perfusion Services 510(k)
Active
510(k) K820727
Overview
The Cardiotomy Reservoirs are classified as Reservoir, Blood, Cardiopulmonary Bypass, designed to collect and temporarily store blood aspirated during cardiotomy procedures. These devices are integral to cardiopulmonary bypass systems, ensuring the safe containment and recirculation of blood during surgical interventions requiring heart-lung support.
Supplied as a reusable medical device, the Cardiotomy Reservoirs are intended for use in controlled clinical environments such as operating rooms. They are regulated under FDA regulation 870.4400 and fall under Device Class 2, with a 510(k) clearance (K820727) granted in 1982. The reservoirs are manufactured by Erik Perfusion Services and adhere to traditional clearance pathways, ensuring compliance with cardiovascular surgical standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820727 | Date8 Jul 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4400
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
Are these Cardiotomy Reservoirs designed for single-use or can they be reused in multiple procedures?
The Cardiotomy Reservoirs are explicitly supplied as a reusable medical device, intended for use in controlled clinical environments like operating rooms during cardiopulmonary bypass procedures. Since they are classified as reusable, they must be properly cleaned, sterilized, and maintained between uses to ensure patient safety and compliance with surgical standards.
What sizes or models of Cardiotomy Reservoirs are available, and how do they differ?
The provided data does not specify exact sizes or model variations (e.g., volume capacities or material differences) for the Cardiotomy Reservoirs. However, they are categorized under Reservoir, Blood, Cardiopulmonary Bypass and are designed to collect and temporarily store aspirated blood during cardiotomy procedures. For precise sizing or model details, refer to the manufacturer’s technical documentation or contact Erik Perfusion Services directly.
How are these reservoirs regulated, and what does the FDA clearance indicate about their use?
The Cardiotomy Reservoirs hold an FDA 510(k) clearance (K820727) under Traditional Clearance, granted in 1982, and are classified as Device Class 2 under regulation 870.4400. This clearance indicates they are deemed substantially equivalent to a legally marketed device already on the market at the time of submission. The clearance does not imply ongoing approval but confirms compliance with FDA standards for use in cardiopulmonary bypass systems during heart surgery.
What clinical environments or surgical procedures are these reservoirs intended for?
The Cardiotomy Reservoirs are designed for use in cardiothoracic operating rooms during cardiopulmonary bypass procedures, specifically where blood is aspirated from the heart and temporarily stored before recirculation. They are integral to surgeries requiring heart-lung support, such as coronary artery bypass grafting or valve replacements, but their intended use is not limited to any single procedure—only to controlled clinical settings where cardiotomy is performed.
How should these reservoirs be stored when not in use, and are there any special handling requirements?
Since the Cardiotomy Reservoirs are reusable, they must be stored in a clean, dry environment when not in use to prevent contamination or damage. The manufacturer’s instructions (not provided in this data) likely outline specific cleaning, sterilization, and storage protocols to maintain functionality and compliance with surgical standards. Always follow the manufacturer’s guidelines to ensure proper handling and longevity of the device.