Aveir Retrieval Catheter— 510(k) K213494

Name: FDA 510(k) clearance K213494
Creator: U.S. Food and Drug Administration
Published: 2022-04-01

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K213494 for Aveir Retrieval Catheter, Substantially Equivalent on 2022-04-01. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code MMX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2021-11-01
Decision date: 2022-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMX

view all

K242776 — LimFlow V-Ceiver2025-02-14
K241259 — Amplatz Goose Neck Snare Kit2024-06-03
K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit2023-09-07
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K222083 — LimFlow V-Ceiver2022-08-09

More clearances from ABBOTT MEDICAL

view all

K262006 — EnSite X EP System2026-07-15
K261631 — Amplatzer TorqVue Exchange System2026-06-17
K253459 — OPTIS Mobile Next Imaging System (1014932) +2 more2026-04-24
K260212 — EnSite X EP System2026-04-20
K253907 — Disposable Radiofrequency Cannula2026-04-16

Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.