Cleared Traditional

PEREGRINE SYSTEM INFUSION CATHETER

K140637 · Ablative Solutions, Inc. · Cardiovascular
Mar 2014
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K140637 is an FDA 510(k) clearance for the PEREGRINE SYSTEM INFUSION CATHETER, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Ablative Solutions, Inc. (Menlo Park, US). The FDA issued a Cleared decision on March 26, 2014, 14 days after receiving the submission on March 12, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K140637 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2014
Decision Date March 26, 2014
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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