Bunegin-Albin Air Aspiration Set— 510(k) K163031

Name: FDA 510(k) clearance K163031
Creator: U.S. Food and Drug Administration
Published: 2017-07-27

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K163031 for Bunegin-Albin Air Aspiration Set, Substantially Equivalent on 2017-07-27. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code DXE
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2016-10-31
Decision date: 2017-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXE

view all

K240078 — Fogarty Thru-Lumen Embolectomy Catheter2024-08-28
K241330 — Fogarty Fortis Arterial Embolectomy Catheter2024-07-02
K233819 — Fogarty Venous Thrombectomy Catheters2024-05-22
K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve2024-05-22
K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters2024-05-20

More clearances from Cook Incorporated

view all

K233177 — Nest VT Vitrification Device2024-03-08
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K223098 — Bakri Essential Postpartum Balloon2022-10-28
K210734 — Endovascular Dilator and Sets2021-04-06
K203670 — Extra Large Check-Flo Introducer2021-02-16

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.