FDA 510(k) Application Details - DEN220026

Device Classification Name

  More FDA Info for this Device
510(K) Number DEN220026
Device Name VasQ
Applicant Laminate Medical Technologies Ltd.
24 Raoul Wallenberg St.
Tel Aviv 6971921 IL
Other 510(k) Applications for this Company
Contact Orit Yarden
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code QVQ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 04/29/2022
Decision Date 09/26/2023
Decision DENG -
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact