Sarns Infant Venous Reservoir Model 16387
510(k) K883345
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883345 | Date28 Sep 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Sarns Infant Venous Reservoir Model 16387 is a blood reservoir designed for use in cardiopulmonary bypass procedures. It collects and temporarily stores venous blood during extracorporeal circulation, ensuring a continuous flow of oxygenated blood to the patient’s circulatory system while the heart is temporarily bypassed. This device is specifically engineered for pediatric and neonatal patients, providing precise control over blood volume and pressure during surgical interventions.
This venous reservoir is supplied as a single-use, sterile device and is intended for use in controlled clinical settings such as operating rooms or cardiac catheterization labs. It is classified as a Class II medical device under FDA regulations (21 CFR 870.4400) and holds an FDA 510(k) clearance (K883345) for substantial equivalence to a predicate device. The device is not MRI-safe and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality prior to use.
Other devices from 3M Health Care, Sarns
Questions
AI-generated answers, 1 Oct 2026
What is the Sarns Infant Venous Reservoir Model 16387 used for?
The Sarns Infant Venous Reservoir Model 16387 is designed specifically for cardiopulmonary bypass procedures in pediatric and neonatal patients. It collects and temporarily stores venous blood during extracorporeal circulation, allowing continuous oxygenated blood flow to the patient’s circulatory system while the heart is temporarily bypassed. This ensures precise control over blood volume and pressure during surgery.
Is the Sarns Infant Venous Reservoir Model 16387 single-use or reusable?
The Sarns Infant Venous Reservoir Model 16387 is supplied as a single-use device. This design ensures sterility and safety for each patient, reducing the risk of cross-contamination and maintaining optimal performance for its intended clinical use.
How should the Sarns Infant Venous Reservoir Model 16387 be stored before use?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. It should be kept in its original, sealed packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Always verify the sterility indicator before use to ensure the device remains uncontaminated.
Can the Sarns Infant Venous Reservoir Model 16387 be used with MRI equipment?
No, the Sarns Infant Venous Reservoir Model 16387 is not MRI-safe. It should not be used or stored in proximity to MRI machines, as this could pose risks to both the device and the patient during imaging procedures.
What regulatory approvals does the Sarns Infant Venous Reservoir Model 16387 hold?
The Sarns Infant Venous Reservoir Model 16387 holds an FDA 510(k) clearance (K883345), demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulations (21 CFR 870.4400). These approvals confirm its compliance with safety and performance standards for use in cardiopulmonary bypass procedures.