Cleared Special

SIDEKICK and USHER Support Catheters

K161986 · Bard Peripheral Vascular, Inc. · Cardiovascular
Aug 2016
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K161986 is an FDA 510(k) clearance for the SIDEKICK and USHER Support Catheters, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on August 4, 2016, 16 days after receiving the submission on July 19, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K161986 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2016
Decision Date August 04, 2016
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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