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Sign in to claim this brandCalyxo, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4473 Willow Road, Pleasanton, CA, 94588
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014683069
- DUNS Number
- 080269404
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CVAC Aspiration System | CVAC70 | FDA UDI | Class II | Active |
| CVAC Image Processor | IMG000020-1 | FDA UDI | Class II | Active |
| CVAC Aspiration System | CVC127020-1 | FDA UDI | Class II | Active |
| CVAC Aspiration System | CVC127020R-1 | FDA UDI | Class II | Active |
| CVAC Aspiration System + CVAC Image Processor | K233472 | FDA 510(k) | Class II | Active |
| CVAC Image Processor | K260013 | FDA 510(k) | Class II | Active |
| CVAC Aspiration System | K260965 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 19, 2025 | Z-1396-2025 | — | open, classified | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure. |