LimFlow V-Ceiver
FDA 510(k) clearance K242776 · decided 2025-02-14
Clearance details
- K-number
- K242776
- Device name
- LimFlow V-Ceiver
- Applicant
- LimFlow, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-13
- Decision date
- 2025-02-14
- Days to decision
- 154 days
- Clearance type
- Special
- Product code
- MMX
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Amplatz Goose Neck Snare Kit (K241259) | Medtronic, Inc. | 2024-06-03 |
| Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K232443) | Argon Medical Devices, Inc. | 2023-09-07 |
| Gunther Tulip Vena Cava Filter Retrieval Set (K222254) | Cook Incorporated | 2023-05-16 |
| LimFlow V-Ceiver (K222083) | LimFlow, Inc. | 2022-08-09 |
| ONO Retrieval Device (K212988) | Onocor Vascular, LLC | 2022-05-23 |
| Aveir Retrieval Catheter (K213494) | ABBOTT MEDICAL | 2022-04-01 |
| Halo Single-Loop Microsnare Kit (K200963) | Argon Medical Devices, Inc. | 2021-01-05 |
| Halo™ Single-Loop Snare Kit (K200268) | Argon Medical Devices, Inc. | 2020-06-03 |
| Merit ONE Snare System (K193507) | Merit Medical Systems, Inc. | 2020-01-17 |
| Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K191758) | Argon Medical Devices, Inc. | 2019-12-17 |
| Günther Tulip® Vena Cava Filter Retrieval Set (K181757) | Cook Incorporated | 2018-11-06 |
| Captus Vascular Retrieval System (K170987) | Avantec Vascular Corporation | 2017-08-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LimFlow System (P220025/S007) | LimFlow, Inc. | 2025-10-22 |
| LimFlow System (P220025/S006) | LimFlow, Inc. | 2025-07-09 |
| LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft (P220025/S005) | LimFlow, Inc. | 2025-02-12 |
| LimFlow System (P220025/S004) | LimFlow, Inc. | 2024-12-20 |
| LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft (P220025/S002) | LimFlow, Inc. | 2024-07-11 |
| LimFlow System (P220025/S003) | LimFlow, Inc. | 2024-04-19 |
| LimFlow System (P220025/S001) | LimFlow, Inc. | 2023-10-12 |
| LimFlow System (P220025) | LimFlow, Inc. | 2023-09-11 |