Cleared Traditional

PiCCO Catheter

K171620 · Pulsion Medical Systems SE · Cardiovascular
Feb 2018
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K171620 is an FDA 510(k) clearance for the PiCCO Catheter, a Probe, Thermodilution (Class II — Special Controls, product code KRB), submitted by Pulsion Medical Systems SE (Feldkirchen, DE). The FDA issued a Cleared decision on February 21, 2018, 264 days after receiving the submission on June 2, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1915.

Submission Details

510(k) Number K171620 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2017
Decision Date February 21, 2018
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRB — Probe, Thermodilution
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1915

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