Cleared Special

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

K072364 · Pulsion Medical Systems AG · Cardiovascular
Sep 2007
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K072364 is an FDA 510(k) clearance for the PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES, a Probe, Thermodilution (Class II — Special Controls, product code KRB), submitted by Pulsion Medical Systems AG (Wake Forest, US). The FDA issued a Cleared decision on September 19, 2007, 28 days after receiving the submission on August 22, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1915.

Submission Details

510(k) Number K072364 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2007
Decision Date September 19, 2007
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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