CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
FDA 510(k) K221934 · Cerenovus, Inc.
510(k) numberK221934
Submission
- Device name
- CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- Applicant
- Cerenovus, Inc.
Miami, FL, US - Received
- July 1, 2022
- Decision date
- March 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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|---|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | Scientia Vascular, Inc. | 07/16/2026SE |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | Penumbra, Inc. | 06/10/2026SE |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/20/2026SE |
| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | QApel Medical, Inc. | 05/07/2026SE |
| K253590 | Millipede SystemNRY · Traditional | Perfuze, Ltd. | 03/16/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 03/12/2026SE |
More from Rapid Medical 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 |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterQJP · Traditional | 10/16/2024SE |
| 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 |
| K221930 | CEREGLIDE 71 Intermediate CatheterQJP · Traditional | 03/09/2023SE |
Questions and answers
When was CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set cleared by the FDA?
CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934) received a 510(k) decision of Substantially Equivalent on March 9, 2023, 251 days after the submission was received.
What is the product code of K221934?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.