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Sign in to claim this brandSumma Therapeutics
US
Last updated May 23, 2026
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Catalogue (103)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS400401508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS200401002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS300601502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS200201502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS400401002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS402250652 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS202250652 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS352251502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS302251002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS350201502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS401000652 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS351001508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS300201002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS302250652 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS352251508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS300600652 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS200601502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS350401002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS350600652 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS402251508 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS250601508 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS202251508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS200401502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS201000652 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS202251002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS401001502 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS350601508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS400601502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS300400652 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS402251502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS400201002 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS300601508 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS250201508 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS300401508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS250401002 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS350401508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS352251002 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS201001508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS300401002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS400200652 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS200401508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS351001002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS250401502 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS350201508 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS300201502 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS250200652 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS200201002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS301001002 | FDA UDI | Class II | Active |
| Finesse BTK Multicath | FS202251502 | FDA UDI | Class II | Active |
| Finesse Injectable PTA Balloon Dilatation Catheter OTW 014 | FS400601508 | FDA UDI | 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. |