Cleared Abbreviated

AMBIT TUNNELER

K110814 · Summit Medical Products, Inc. · Anesthesiology
Apr 2011
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K110814 is an FDA 510(k) clearance for the AMBIT TUNNELER, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Summit Medical Products, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 8, 2011, 15 days after receiving the submission on March 24, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K110814 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2011
Decision Date April 08, 2011
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

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