FOURSNARE VASCULAR RETRIEVAL SNARE— 510(k) K112185

Clearance details

Applicant

Cook, Inc.

Product code

Code MMX

Device class

Class 2

Regulation

21 CFR 870.5150

Advisory panel

Cardiovascular

Date received

2011-07-29

Decision date

2011-11-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, IN, US

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• K131772 — CANTATA(R) 2.9 MICROCATHETER2014-02-20

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 →

• Z-2243-2014 — CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.Class I·Terminated·Cook Inc.·20140717

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112185.