CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
FDA 510(k) clearance K221934 · decided 2023-03-09
Clearance details
- K-number
- K221934
- Device name
- CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- Applicant
- Cerenovus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-01
- Decision date
- 2023-03-09
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- NRY
- 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 |
|---|---|---|
| Socrates Aspiration System (Socrates 70 Aspiration Catheter) (K260002) | Scientia Vascular, Inc. | 2026-07-16 |
| Penumbra System (Thunderbolt Aspiration Tubing) (K250690) | Penumbra, Inc. | 2026-06-10 |
| Zenith Aspiration Catheter; Disposable Aspiration Tubing Set (K252707) | Suzhou Zenith Vascular SciTech Limited | 2026-05-20 |
| Lynx Aspiration Catheter System (K254276) | Q’Apel Medical, Inc. | 2026-05-07 |
| Millipede System (K253590) | Perfuze, Ltd. | 2026-03-16 |
| Tigertriever 25 Revascularization Device (K253062) | Rapid Medical Ltd. | 2026-03-12 |
| Esperance pHLO Aspiration System (K251357) | Phenox, Ltd. | 2026-01-15 |
| NeVasc Aspiration System (K251006) | Vesalio, Inc. | 2025-11-10 |
| Zoom System (Zoom 4S Catheter) (K252046) | Imperative Care, Inc. | 2025-10-30 |
| Tigertriever 17 Ultra Revascularization Device (K251603) | Rapid Medical Ltd. | 2025-10-06 |
| EMBOTRAP III Revascularization Device (K251789) | Neuravi Limited | 2025-09-25 |
| Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392) | Perfuze, Ltd. | 2025-08-29 |
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 |