Jostra Retrograde Cardioplegia Cannulae
by Jostra AG 510(k)
Active
510(k) K014303
Overview
The Jostra Retrograde Cardioplegia Cannulae are vascular catheters designed for use during cardiopulmonary bypass. These devices deliver blood or cardioplegia arrest solution to myocardial tissue via the coronary sinus.
This single-use, sterile device consists of a 14 Fr. polyvinyl chloride cannula with an integrated balloon, optional pressure monitoring lines, and a choice of stiff or flexible stylets. The device is authorized via FDA 510(k) clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK014303 | Date26 Mar 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- Withdrawn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 clinical use of the Jostra Retrograde Cardioplegia Cannulae?
These vascular catheters are designed for use during cardiopulmonary bypass procedures. Their specific function is to deliver blood or cardioplegia arrest solution directly to the myocardial tissue via the coronary sinus.
Are these cannulae intended for single-use or can they be reprocessed?
The Jostra Retrograde Cardioplegia Cannulae are single-use devices. This designation ensures that the sterility and structural integrity of the polyvinyl chloride cannula and integrated balloon are maintained for each patient procedure.
What are the physical specifications of this device?
The device is a 14 Fr. polyvinyl chloride cannula. It features an integrated balloon and is available with a choice of either stiff or flexible stylets, as well as optional pressure monitoring lines to assist the clinician during use.
What is the regulatory status of this device?
The Jostra Retrograde Cardioplegia Cannulae are authorized via FDA 510(k) clearance. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.