QVQ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Extravascular Support For An Arteriovenous Fistula For Vascular Access
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4600
- Medical specialty
- Cardiovascular
- Flags
- Implant
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| VasQ (K240119) | Laminate Medical Technologies , Ltd. | 2024-02-16 |
| VasQ (DEN220026) | Laminate Medical Technologies , Ltd. | 2023-09-26 |
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