Quantum Perfusion Blood Oxygenator ECC VT160-E3 - Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
510(k) K240934
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240934 | Date12 Mar 2026 | 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- Withdrawn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
- DTZ
- Models / Variants
- Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4350
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Quantum Perfusion Blood Oxygenator ECC (VT160-E3, VT200-E3, VT75-E3) is a diffusion membrane oxygenator designed for cardiopulmonary bypass procedures. It facilitates oxygenation and carbon dioxide removal from venous blood during cardiac surgery, maintaining blood pressure and temperature monitoring during use. These devices are classified as oxygenators under FDA regulation 870.4350 and are intended for adult patients only.
Supplied as single-use devices, the Quantum Perfusion Blood Oxygenator ECC models are intended for up to six hours of use in controlled surgical environments. They are regulated under FDA 510(k) clearance (K240934) and fall under product code DTZ, with a classification as Class II medical devices. Sterility and MRI safety are not specified in the available data.