VasQ
FDA 510(k) clearance DEN220026 · decided 2023-09-26
Clearance details
- K-number
- DEN220026
- Device name
- VasQ
- Applicant
- Laminate Medical Technologies , Ltd.
- Decision
- Unknown
- Date received
- 2022-04-29
- Decision date
- 2023-09-26
- Days to decision
- 515 days
- Clearance type
- Direct
- Product code
- QVQ
- Device class
- 2
- Regulation number
- 870.4600
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VasQ (K240119) | Laminate Medical Technologies , Ltd. | 2024-02-16 |
Recalls involving this device
No recalls on record reference this clearance.