Jostra Dual Stage Venous Return Cannulae
by Jostra AG 510(k)
Active
510(k) K013944
Overview
The Jostra Dual Stage Venous Return Cannulae are a type of Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass, designed for extracorporeal circulation. These dual-stage cannulae facilitate venous drainage from the right atrium and inferior vena cava, diverting blood into an extracorporeal circuit during surgical procedures.
Intended for single-use in surgical settings, these cannulae are sterile and supplied as a disposable device. They are classified as Class II under FDA regulations (Regulation Number 870.4210) and have received FDA 510(k) clearance as substantially equivalent. Multiple sizes and configurations are available, as indicated by the associated product codes, ensuring compatibility with various extracorporeal circulation systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013944 | Date11 Feb 2002 | 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- Withdrawn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
- DWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4210
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Jostra AG
Questions
What is the primary purpose of the Jostra Dual Stage Venous Return Cannulae in surgical settings?
The Jostra Dual Stage Venous Return Cannulae are designed specifically for extracorporeal circulation during surgical procedures. They facilitate venous drainage from the right atrium and inferior vena cava, directing blood into an external circuit to support the patient’s circulation while the heart is temporarily bypassed.
Are these cannulae intended for reuse or are they single-use devices?
These cannulae are explicitly labeled for single-use only in surgical settings. They are supplied sterile and packaged as disposable devices, ensuring compliance with infection control protocols for each procedure.
How many sizes or configurations are available, and how do I determine compatibility with my system?
Multiple sizes and configurations are available, as indicated by the product codes listed in the FDA submission (e.g., DWF category). Compatibility depends on your extracorporeal circulation system’s requirements—refer to the manufacturer’s documentation or contact Jostra AG (contact: Kathleen Johnson) for guidance on selecting the correct size for your setup.
What storage conditions should I follow for these cannulae before use?
Since these are sterile, single-use devices, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the expiration date printed on the packaging before use.
What regulatory pathway was followed for FDA clearance of these cannulae?
The Jostra Dual Stage Venous Return Cannulae received FDA 510(k) clearance under the Traditional pathway, with a decision date of February 11, 2002. They were determined to be substantially equivalent to a predicate device and fall under FDA classification 870.4210 (Class II) for vascular cannulae used in cardiopulmonary bypass.