510(k) DEN220026
DEN220026 is an FDA 510(k) premarket notification submitted by Laminate Medical Technologies , Ltd. for the device "VasQ". The FDA issued a decision of De Novo Granted on September 26, 2023. The device falls under product code QVQ (Extravascular Support For An Arteriovenous Fistula For Vascular Access), a Class II device regulated under 21 CFR 870.4600. Laminate Medical Technologies , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 26, 2023
- Date Received
- April 29, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extravascular Support For An Arteriovenous Fistula For Vascular Access
- Device Class
- Class II
- Regulation Number
- 870.4600
- Review Panel
- CV
- Submission Type
This device is a permanent implant which is surgically placed outside and/or around an artery and/or vein to provide external support to arteriovenous fistulas created for vascular access by means of vascular surgery.