NovaPort One Vascular Access Cannula
510(k) K112565
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112565 | Date6 Dec 2011 | 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- Withdrawn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 NovaPort One Vascular Access Cannula is a catheter, cannula, and tubing device for vascular access, designed for use in cardiopulmonary bypass and extracorporeal support systems. It facilitates percutaneous connection between extracorporeal gas exchange systems and the vascular system, enabling secure vascular access during procedures such as minimally invasive heart surgery and perioperative perfusion. Constructed for compatibility with 3/8-inch tube connections, it integrates into extracorporeal circuits to maintain hemodynamic stability during critical interventions.
This device is supplied as a single-use, sterile product and is classified as Class II under FDA regulations (DWF product code, 870.4210). It is intended for use in controlled clinical environments, such as operating rooms or cardiac catheterization labs, where sterile techniques are mandatory. The cannula is non-magnetic and MRI-safe, ensuring compatibility with imaging modalities when required. Available in specific sizes and configurations, it is regulated under FDA 510(k) clearance (K112565) and adheres to cardiovascular device standards for extracorporeal support applications.
Other devices from Novalung GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the NovaPort One Vascular Access Cannula used for?
The NovaPort One Vascular Access Cannula is designed for percutaneous connection between extracorporeal gas exchange systems and the vascular system. It enables secure vascular access during cardiopulmonary bypass and extracorporeal support procedures, such as minimally invasive heart surgery and perioperative perfusion. This ensures stable hemodynamic support during critical interventions.
How is the NovaPort One Vascular Access Cannula supplied and what are its sterility and reuse specifications?
The NovaPort One Vascular Access Cannula is supplied as a single-use, sterile product. It is intended for use in controlled clinical environments like operating rooms or cardiac catheterization labs, where sterile techniques are mandatory. Due to its single-use nature, it cannot be reused after a single procedure.
What tube connection compatibility does the NovaPort One Cannula have?
The NovaPort One Vascular Access Cannula is constructed for compatibility with 3/8-inch tube connections. This ensures seamless integration into extracorporeal circuits, maintaining hemodynamic stability during critical procedures.
Is the NovaPort One Vascular Access Cannula MRI-safe?
Yes, the NovaPort One Vascular Access Cannula is non-magnetic and MRI-safe. This allows for compatibility with imaging modalities when required during procedures, ensuring patient safety and procedural flexibility.
What sizes and configurations are available for the NovaPort One Vascular Access Cannula?
The NovaPort One Vascular Access Cannula is available in specific sizes and configurations tailored for vascular access in cardiopulmonary bypass and extracorporeal support systems. While exact sizes are not detailed in the provided data, the device is designed to meet the requirements of these specialized applications, ensuring compatibility with various patient anatomies and procedural needs.