| K-number | K252694 |
| Device name | Target Detachable Coil |
| Applicant | Stryker Neurovascular |
| Product code | HCG |
| Device class | Class II |
| Decision date | Dec 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.5950 |
Target Detachable Coils are stretch-resistant, electrolytically detachable coils made of platinum-tungsten alloy attached to a stainless steel delivery wire, designed for endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and arterial/venous abnormalities in peripheral vasculature. They are used with Stryker's InZone Detachment System and compatible 2-tip marker microcatheters.
The subject device is identical to predicate K242243 in all material composition, design features (secondary coil diameter 1–24 mm, length 1–50 cm, shapes including Helical/360/3D/Tetrahedral), sterilization method (ethylene oxide gas), packaging, and power supply compatibility. The sole change is expanded labeling to support transradial access in addition to the previously approved transfemoral access.
Not stated in this summary.
The proposed changes do not alter the intended use, indications for use, or fundamental scientific technology of the predicate device. Bench testing demonstrated no noticeable differences in microcatheter friction, ease of deployment/retraction, or device behavior between radial and femoral access routes, with no statistical differences in tracking forces. Since the risk assessment raises no new safety or effectiveness questions, the device is substantially equivalent to predicate K242243.
View the full FDA submission: accessdata.fda.gov