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Sign in to claim this brandSumma Therapeutics
US
Last updated May 23, 2026
What Summa Therapeutics makes
Summa Therapeutics manufactures peripheral angioplasty balloon catheters and single-use angiographic catheters. Their product line includes the Finesse Injectable PTA Balloon Dilatation Catheter OTW 014, designed for vascular dilation, and the Finesse BTK Multicath, intended for angiographic imaging of the below-the-knee arteries.
These devices are classified as Class II under FDA regulations and are recorded in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Summa Therapeutics manufacture?
Summa Therapeutics specializes in two primary device categories: peripheral angioplasty balloon catheters and single-use angiographic catheters. Their peripheral angioplasty balloon catheters, like the Finesse Injectable PTA Balloon Dilatation Catheter OTW 014, are used to dilate narrowed or blocked blood vessels in the peripheral arteries. The angiographic catheters, such as the Finesse BTK Multicath, are designed for imaging below-the-knee arteries, helping clinicians visualize blood flow and vascular structure during procedures.
Where is Summa Therapeutics based?
Summa Therapeutics is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under U.S. medical device regulations, including those enforced by the FDA.
Which regulatory registries list Summa Therapeutics’ devices?
Summa Therapeutics’ devices are recorded in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary regulatory pathways, such as the 510(k) process, which demonstrates substantial equivalence to a legally marketed predicate device. The UDI system ensures traceability and identification of devices throughout their lifecycle.
How are Summa Therapeutics’ devices classified under FDA regulations?
Summa Therapeutics’ devices, including both peripheral angioplasty balloon catheters and angiographic catheters, are classified as Class II under FDA regulations. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness. This classification reflects the moderate risk associated with these devices, which are used in procedures like vascular dilation and imaging but do not pose the highest risk levels seen in Class III devices.
AI-generated from registry data and not verified by a human reviewer.
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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.
Summa Therapeutics has one FDA recall record initiated on July 21, 2025. The recall is listed with two statuses: open and classified. The reason provided is a potential for the balloon in the device to not meet burst specifications.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |