Cleared Traditional

Bard Snare Retrieval Kit

K152560 · Neometrics, Inc. · Cardiovascular
Oct 2015
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K152560 is an FDA 510(k) clearance for the Bard Snare Retrieval Kit, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 23, 2015, 44 days after receiving the submission on September 9, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K152560 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2015
Decision Date October 23, 2015
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MMX — Device, Percutaneous Retrieval
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

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