CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
FDA 510(k) K241244 · Cerenovus, Inc.
510(k) numberK241244
Submission
- Device name
- CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
- Applicant
- Cerenovus, Inc.
Miami, FL, US - Received
- May 2, 2024
- Decision date
- October 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJP – Catheter, Percutaneous, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Other 510(k)s with product code QJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262277 | 70 NeuGlide CatheterQJP · Special | Piraeus Medical, Inc. | 09/04/2026SE |
| K261176 | Zoom 4S CatheterQJP · Traditional | Imperative Care, Inc. | 08/28/2026SE |
| K254071 | p17 XR MicrocatheterQJP · Traditional | Wallaby Medical | 08/18/2026SE |
| K260199 | SLIM MicrocatheterQJP · Traditional | Balt USA, LLC | 07/13/2026SE |
| K253901 | Millipede88 Access CatheterQJP · Traditional | Perfuze, Ltd. | 07/09/2026SE |
| K261889 | Trevo Trak 21 MicrocatheterQJP · Special | Stryker Neurovascular | 07/01/2026SE |
| K261808 | ISAAC Neurovascular Navigation CatheterQJP · Special | Microvention Inc. d/b/a Terumo Neuro | 06/30/2026SE |
| K261549 | BOBBY Balloon Guide CatheterQJP · Special | MicroVention, Inc., d/b/a Terumo Neuro | 06/09/2026SE |
| K253359 | Zenith Distal Access Long SheathQJP · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/22/2026SE |
| K254178 | SAYA 86 Radial Access Guide CatheterQJP · Traditional | Asahi Intecc Co., Ltd. | 05/11/2026SE |
More from Asahi Intecc Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | 08/14/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | 08/13/2026SE |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetNRY · Special | 08/22/2025SE |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…NRY · Traditional | 10/16/2024SE |
| K233982 | CEREGLIDE 92 Catheter SystemQJP · Special | 05/09/2024SE |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetNRY · Special | 01/17/2024SE |
| K230726 | CEREGLIDE 92 Intermediate CatheterQJP · Traditional | 11/29/2023SE |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetNRY · Traditional | 03/09/2023SE |
| K221930 | CEREGLIDE 71 Intermediate CatheterQJP · Traditional | 03/09/2023SE |
Questions and answers
When was CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter cleared by the FDA?
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244) received a 510(k) decision of Substantially Equivalent on October 16, 2024, 167 days after the submission was received.
What is the product code of K241244?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.