Cleared Traditional

FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET

K140110 · Teleflex, Inc. · Anesthesiology
Mar 2015
Decision
436d
Days
Class 2
Risk

About This 510(k) Submission

K140110 is an FDA 510(k) clearance for the FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Teleflex, Inc. (Reading, US). The FDA issued a Cleared decision on March 27, 2015, 436 days after receiving the submission on January 15, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K140110 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2014
Decision Date March 27, 2015
Days to Decision 436 days
Submission Type Traditional
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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