Aveir Retrieval Catheter
FDA 510(k) clearance K213494 · decided 2022-04-01
Clearance details
- K-number
- K213494
- Device name
- Aveir Retrieval Catheter
- Applicant
- ABBOTT MEDICAL
- Decision
- Substantially Equivalent
- Date received
- 2021-11-01
- Decision date
- 2022-04-01
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- MMX
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sylmar, 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 |
|---|---|---|
| LimFlow V-Ceiver (K242776) | LimFlow, Inc. | 2025-02-14 |
| 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 |
| 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 |
|---|---|---|
| Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092) | ABBOTT MEDICAL | 2025-12-23 |
| Proclaim Spinal Cord Stimulation (SCS) System (P010032/S246) | ABBOTT MEDICAL | 2025-12-23 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S127) | ABBOTT MEDICAL | 2025-12-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S014) | ABBOTT MEDICAL | 2025-12-23 |
| Volt PFA System (P250022) | ABBOTT MEDICAL | 2025-12-19 |
| HeartMate II Left Ventricular Assist System (P060040/S122) | ABBOTT MEDICAL | 2025-12-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S116) | ABBOTT MEDICAL | 2025-12-17 |
| Durata Leads; Optisure Leads (P950022/S151) | ABBOTT MEDICAL | 2025-12-09 |