Cerenovus, Inc. · Class II · Cleared Aug 22, 2025
| K-number | K251828 |
| Device name | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set |
| Applicant | Cerenovus, Inc. |
| Product code | NRY |
| Device class | Class II |
| Decision date | Aug 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The CEREGLIDE 71 Catheter System is a neurovascular catheter used to treat acute ischemic stroke by removing blood clots through aspiration or delivering interventional devices. It consists of a variable stiffness single-lumen catheter with a PTFE liner, hydrophilic coating, and radiopaque marker, packaged with the INNERGLIDE 7 Delivery Aid, hemostasis valve, and slit introducers for facilitating catheter placement in cerebral blood vessels.
The device is identical to its predicate in all material respects: same catheter dimensions (115-137 cm length, 0.071" ID), materials (platinum/iridium marker band, stainless steel braid, PTFE liner, Pebax/urethane jacket), hydrophilic coating specifications, and basic design as a variable stiffness single-lumen catheter. The primary addition is the INNERGLIDE 7 Delivery Aid with specifications of 165 cm length, 0.030" ID, hydrophilic coating over 30 cm, and tungsten marker band—a support device for facilitating catheter delivery.
ISO 10555-1 (catheter visual inspection, dimensions, working length, air leak resistance, pressure integrity, burst pressure, flexibility, tracking); ISO 80369-7 (Luer hub interconnectability); ISO 11135 (ethylene oxide sterilization); EN ISO 10993-7 (biocompatibility); ISO 10993-7 (ethylene oxide residuals); ISO 10555-1 section 4.11 (system air leak resistance).
Substantial equivalence is established because: (1) the CEREGLIDE 71 Intermediate Catheter core component is unchanged from the predicate and maintains identical dimensions, materials, and specifications; (2) the newly added INNERGLIDE 7 Delivery Aid uses identical materials (PTFE, hydrophilic coating, tungsten marker) to the already-cleared INNERGLIDE 9 (K233982), whose biocompatibility testing provides supporting evidence; (3) comprehensive bench testing including dimensional verification, pressure testing, coating durability, and in vitro usability studies all passed established acceptance criteria; and (4) the delivery aid performs a supportive function without changing the fundamental intended use or safety profile of the catheter system.
View the full FDA submission: accessdata.fda.gov