510(k) K240119
- Device
- VasQ
- Applicant
- Laminate Medical Technologies , Ltd.
- 510(k) number
- K240119
- Product code
- QVQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-16
- Date received
- 2024-01-16
- Regulation
- 870.4600
- Classification name
- Extravascular Support For An Arteriovenous Fistula For Vascular Access
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Orit Yarden
- Address
- 24 Raoul Wallenberg Tel Aviv IL 6971921 6971921
FDA Registration Numbers#
- 3015192261
- 3002808227
- 3011693567
Source Documents#
Other 510(k) Records For Product Code QVQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220026 | VasQ | Laminate Medical Technologies , Ltd. | 2023-09-26 |