Nmi Antegrad Cardioplegia Cannula
510(k) K961180
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961180 | Date21 Jun 1996 | 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- Withdrawn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
- DWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4210
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NMI Antegrade Cardioplegia Cannula is a vascular catheter designed for cardiopulmonary bypass procedures. It delivers cardioplegia solutions directly to the heart during cardiac surgery while also allowing ventilation of the ascending aorta to remove air or cardioplegia fluid. Constructed primarily of PVC, it includes a radiopaque tip, a stainless steel stylet, and connectors for secure attachment to perfusion systems.
This device is intended for single-use in controlled surgical environments and is classified as a Class II medical device under FDA regulation 870.4210. Supplied sterile, it requires no additional sterilisation before use. The cannula is compatible with standard cardiopulmonary bypass circuits and is available in sizes specified in the manufacturer’s documentation. Its design adheres to FDA clearance (510(k) K961180) and is intended for use in cardiovascular surgical settings only.
Other devices from Naltiac Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the NMI Antegrade Cardioplegia Cannula used for?
The NMI Antegrade Cardioplegia Cannula is designed specifically for cardiopulmonary bypass (CPB) procedures. It delivers cardioplegia solutions directly into the heart to induce temporary cardiac arrest during surgery, while simultaneously allowing ventilation of the ascending aorta. This dual function helps remove air or excess cardioplegia fluid, ensuring optimal surgical conditions for cardiovascular procedures.
How is the cannula supplied and prepared for use?
The cannula is supplied sterile and ready for single-use in controlled surgical environments. No additional sterilization is required before use, as it is pre-sterilized by the manufacturer. This ensures immediate availability for surgical procedures without extra preparation steps.
Is the cannula reusable or intended for single-use only?
The NMI Antegrade Cardioplegia Cannula is explicitly designed for single-use only. This design choice minimizes the risk of contamination and cross-infection between patients, adhering to best practices for medical device safety in surgical settings.
What materials is the cannula constructed from, and what features does it include?
The cannula is primarily constructed from polyvinyl chloride (PVC) for flexibility and durability. It includes a radiopaque tip to ensure visibility under fluoroscopy during surgery, a stainless steel stylet for structural support, and connectors compatible with standard cardiopulmonary bypass circuits. These features enhance precision and safety during use.
How should the cannula be stored before use?
The cannula should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and maintains the integrity of the device until use. Always follow the manufacturer’s instructions for storage to preserve functionality and safety.