510(k) K240119
K240119 is an FDA 510(k) premarket notification submitted by Laminate Medical Technologies , Ltd. for the device "VasQ". The FDA issued a decision of Substantially Equivalent on February 16, 2024. 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
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2024
- Date Received
- January 16, 2024
- Clearance Type
- Special
- 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.