Vacuum-Assisted Blood Collection System
by Jtl Medical Corp. 510(k)
Active
510(k) K905818
Overview
This device is a Reservoir, Blood, Cardiopulmonary Bypass as classified under FDA regulation 870.4400. It is designed to facilitate the collection and containment of blood during cardiopulmonary bypass procedures, ensuring efficient and controlled blood management in surgical settings.
The system is intended for single-use in clinical environments and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device. It is supplied sterile and must be handled according to standard aseptic protocols. No additional regulatory markings or MRI safety considerations are specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905818 | Date6 Jun 1991 | 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- Withdrawn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
- DTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4400
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Jtl Medical Corp.
Questions
What is the primary purpose of the Vacuum-Assisted Blood Collection System in surgical settings?
The Vacuum-Assisted Blood Collection System is specifically designed to collect and contain blood during cardiopulmonary bypass procedures. It helps ensure efficient and controlled blood management, reducing the risk of spillage or loss while the patient is on bypass.
Is the Vacuum-Assisted Blood Collection System intended for reuse, or is it meant for single-use only?
The system is explicitly labeled for single-use only in clinical environments. This ensures sterility and safety, requiring adherence to standard aseptic protocols during handling and use.
How is the Vacuum-Assisted Blood Collection System supplied, and what sterility guarantees are provided?
The device is supplied sterile as part of its design specifications. This means it is pre-sterilized and packaged to maintain sterility until use, requiring no additional sterilization by the healthcare facility.
What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?
The Vacuum-Assisted Blood Collection System received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II device. This classification indicates it poses moderate risk and requires compliance with specific regulatory controls.
Are there any special handling or storage requirements for this device beyond standard clinical protocols?
Beyond standard aseptic handling, the device does not specify additional storage requirements in the available data. However, since it is sterile and single-use, it should be stored in its original packaging until use to preserve sterility and integrity.