CEREGLIDE 92 Catheter System
FDA 510(k) clearance K233982 · decided 2024-05-09
Clearance details
- K-number
- K233982
- Device name
- CEREGLIDE 92 Catheter System
- Applicant
- Cerenovus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-18
- Decision date
- 2024-05-09
- Days to decision
- 143 days
- Clearance type
- Special
- Product code
- QJP
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SLIM Microcatheter (K260199) | Balt USA, LLC | 2026-07-13 |
| Millipede88 Access Catheter (K253901) | Perfuze, Ltd. | 2026-07-09 |
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
| ISAAC Neurovascular Navigation Catheter (K261808) | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 |
| BOBBY Balloon Guide Catheter (K261549) | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 |
| Zenith Distal Access Long Sheath (K253359) | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 |
| SAYA 86 Radial Access Guide Catheter (K254178) | Asahi Intecc Co., Ltd. | 2026-05-11 |
| BosCATH Support Catheter (K254046) | Sonorous NV, Inc. | 2026-04-21 |
| Next Generation 088 Catheter (K254223) | Balt USA, LLC | 2026-04-16 |
| PATH BGC (K260938) | Crossroads Neurovascular, Inc. | 2026-04-15 |
| Radical 6F Access Catheter (K253975) | Maduro Medical, Inc. | 2026-04-09 |
| AXS Lift Intracranial Base Catheter (K253032) | Stryker Neurovascular | 2026-02-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set (P990040/S034) | Cerenovus, Inc. | 2025-12-16 |
| TRUFILL n-BCA Liquid Embolic System (P990040/S036) | Cerenovus, Inc. | 2025-08-22 |
| TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set (P990040/S035) | Cerenovus, Inc. | 2025-05-28 |
| TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S033) | Cerenovus, Inc. | 2024-07-02 |
| TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set (P990040/S032) | Cerenovus, Inc. | 2024-02-13 |
| TRUFILL™ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S031) | Cerenovus, Inc. | 2023-09-29 |
| TRUFILL n-BCA Liquid Embolic System (P990040/S030) | Cerenovus, Inc. | 2023-02-28 |
| TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S029) | Cerenovus, Inc. | 2019-09-18 |