Aveir Retrieval Catheter
FDA 510(k) K213494 · Abbott Medical
510(k) numberK213494
Submission
- Device name
- Aveir Retrieval Catheter
- Applicant
- Abbott Medical
Sylmar, CA, US - Received
- November 1, 2021
- Decision date
- April 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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| K193507 | Merit ONE Snare SystemMMX · Special | Merit Medical Systems, Inc. | 01/17/2020SE |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX · Traditional | Argon Medical Devices, Inc. | 12/17/2019SE |
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Questions and answers
When was Aveir Retrieval Catheter cleared by the FDA?
Aveir Retrieval Catheter (K213494) received a 510(k) decision of Substantially Equivalent on April 1, 2022, 151 days after the submission was received.
What is the product code of K213494?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.