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Sign in to claim this brandSumma Therapeutics
US
Last updated May 23, 2026
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Catalogue (103)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Finesse™ Injectable PTA Balloon Dilatation Catheter | K230263 | FDA 510(k) | Class II | Active |
| Finesse Injectable™ PTA Balloon Dilatation Catheter | K241740 | FDA 510(k) | Class II | Active |
| ComboCath OTW PTA Dilatation Catheter | K150452 | 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 |
|---|---|---|---|---|
| Jul 21, 2025 | Z-1704-2026 | — | open, classified | Potential for the balloon in the device to not meet burst specifications. |