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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Toro Neurovascular's Toro 88 Superbore Catheter

The Irvine startup's first commercial product is a large-bore access catheter, which Kaneka Medical America will launch in the US in phases.

By News DeskMarch 11, 20262 min read
Two grayscale X-ray angiography views showing blood vessels of the brain
Cerebral angiography images of the right internal carotid artery. Not a procedure using the Toro 88 catheter described in this article. U2em, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA cleared510(k) · K252297FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared the Toro 88 Superbore Catheter under 510(k) K252297 on January 16, 2026; Toro Neurovascular announced the clearance on March 11.
  • The cleared indication is the introduction of interventional devices into the peripheral, coronary and neuro vasculature; the company is aiming it at stroke procedures.
  • The 510(k) summary says substantial equivalence rested on bench testing, with no animal or clinical data required.

Toro Neurovascular has received US Food and Drug Administration 510(k) clearance for its Toro 88 Superbore Catheter, a large-bore neurovascular access catheter, and has begun commercial introduction of the device, the company announced on March 11, Endovascular Today reported.

Kaneka Medical America, part of Japan's Kaneka Corporation, will lead the US launch under the companies' collaboration, and the two plan a phased rollout, according to the report. Toro said additional product launches and portfolio expansion are also planned.

What the FDA cleared

The FDA's 510(k) database lists the clearance as K252297 for the Toro 88 Superbore Catheter, made by Irvine, California-based Toro Neurovascular. The agency received the traditional 510(k) on July 23, 2025, and found the device substantially equivalent on January 16, 2026, nearly two months before the announcement. The neurology panel reviewed it under the percutaneous neurovasculature catheter product code.

According to the clearance letter and 510(k) summary, the device "is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature." It is a variable-stiffness, single-lumen catheter built from stainless steel and nitinol wires and polymers, with a lubricious inner liner, a hydrophilic coating on the distal section and one radiopaque tip marker.

The summary gives an inner diameter of 0.088 inches along its length and an effective length of 118 cm. The predicates are the TracStar LDP Large Distal Platform and the Zoom 88 Large Distal Platform devices, cleared together as K240948, which share the same inner diameter and indication.

For both animal and clinical performance data, the summary states that "A determination of substantial equivalence is based upon successful completion of bench performance testing." Testing listed includes biocompatibility, tensile strength and burst pressure work.

Company claims

The company described the Toro 88 as its first commercial neurovascular catheter platform and said it provides superbore inner-diameter capability while maintaining control, responsiveness and distal access performance for stroke interventions. Those are company claims; the FDA indication is not limited to stroke.

Toro said the first US clinical use of the catheter was performed by Satoshi Tateshima, professor of interventional neuroradiology at UCLA. "Large-bore catheters demonstrate clear clinical value," Tateshima said in the company's release, as quoted by Endovascular Today. He added that the catheter's "navigation and trackability matched the design expectations."

The company did not disclose pricing or the number of hospitals in the initial rollout in the coverage reviewed.

Sources

  1. Toro Neurovascular's Toro 88 Superbore Catheter Cleared by FDA, Endovascular Today, March 11, 2026
  2. 510(k) K252297: Toro 88 Superbore Catheter (database record), US Food and Drug Administration, January 16, 2026
  3. K252297 clearance letter and 510(k) summary, US Food and Drug Administration, January 16, 2026