510(k) K263598
- Device
- VasQ
- Applicant
- Laminate Medical Technologies
- 510(k) number
- K263598
- Product code
- QVQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-29
- Date received
- 2026-09-30
- 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
- N
Applicant Contact#
- Contact
- Orit Yarden
- Address
- 24 Raoul Wallenberg St. Tel Aviv IL 6971921 6971921
FDA Registration Numbers#
- 3002808227
- 3015192261
- 3011693567