Cleared Traditional

PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046

K020587 · Pulsion Medical Systems AG · Cardiovascular
May 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K020587 is an FDA 510(k) clearance for the PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046, a Probe, Thermodilution (Class II — Special Controls, product code KRB), submitted by Pulsion Medical Systems AG (Concord, US). The FDA issued a Cleared decision on May 23, 2002, 90 days after receiving the submission on February 22, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1915.

Submission Details

510(k) Number K020587 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2002
Decision Date May 23, 2002
Days to Decision 90 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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