Sarns MP4 Cardioplegia Delivery System
510(k) K883071
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883071 | Date5 Dec 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- Withdrawn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
- DTR
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4240
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sarns MP4 Cardioplegia Delivery System is a heat-exchanger device used in cardiopulmonary bypass procedures. It is designed to deliver cardioplegic solutions to the heart during cardiac surgery, ensuring myocardial protection by maintaining optimal temperature and flow rates. This system integrates with perfusion circuits to facilitate precise administration of cardioplegia while supporting circulatory support during open-heart interventions.
The system is intended for single-use in controlled clinical settings, such as operating rooms equipped for cardiac surgery. It is classified as a Class II medical device under FDA regulations (870.4240) and has received FDA 510(k) clearance (K883071) for traditional review. Supplied sterile and pre-connected, the device requires proper handling and disposal per manufacturer guidelines to ensure sterility and functionality. No MRI safety information is specified, and its compatibility with other perfusion systems should be verified prior to use.
Other devices from 3M Health Care, Sarns
Questions
AI-generated answers, 1 Oct 2026
What is the Sarns MP4 Cardioplegia Delivery System used for?
The Sarns MP4 Cardioplegia Delivery System is designed specifically for cardiopulmonary bypass procedures in cardiac surgery. It delivers cardioplegic solutions directly to the heart to protect myocardial tissue during open-heart interventions. By maintaining optimal temperature and flow rates, it supports circulatory stability while the heart is temporarily stopped for surgical repairs.
Is the Sarns MP4 Cardioplegia Delivery System reusable or single-use?
The Sarns MP4 Cardioplegia Delivery System is intended for single-use only in controlled clinical settings, such as operating rooms. This design ensures sterility and functionality for one procedure, reducing the risk of contamination or cross-infection. After use, it must be disposed of according to manufacturer guidelines to maintain compliance with sterile medical device protocols.
How is the Sarns MP4 Cardioplegia Delivery System supplied?
The system is supplied sterile and pre-connected, ready for immediate use in cardiac surgery. This pre-assembled configuration simplifies setup in the operating room, allowing clinicians to focus on patient care without additional preparation steps. Proper handling and storage per manufacturer instructions are required to preserve sterility before use.
Can the Sarns MP4 Cardioplegia Delivery System be used with any perfusion circuit?
While the Sarns MP4 is designed to integrate with perfusion circuits, compatibility with other systems should be verified prior to use. The manufacturer does not specify MRI safety information, so clinicians must confirm the system’s compatibility with their specific perfusion setup to avoid operational issues or safety risks during surgery.
What regulatory approval does the Sarns MP4 Cardioplegia Delivery System hold?
The Sarns MP4 Cardioplegia Delivery System has received FDA 510(k) clearance (K883071) under traditional review, classifying it as a Class II medical device (FDA product code: DTR, 870.4240). This approval confirms its compliance with U.S. regulatory standards for heat-exchanger devices used in cardiopulmonary bypass procedures.