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FDA 510(k)

PiCCO Catheter

K-Number: K171620 · 2018-02-21

ApplicantPulsion Medical Systems SE
Decision Date2018-02-21
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PiCCO Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pulsion Medical Systems SE. It received FDA 510(k) clearance on 2018-02-21 under 510(k) number K171620. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PiCCO Catheter?

PiCCO Catheter is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is Pulsion Medical Systems SE. The 510(k) number is K171620.

When did PiCCO Catheter receive FDA 510(k) clearance?

PiCCO Catheter received FDA 510(k) clearance on 2018-02-21, under 510(k) number K171620.

Who is the listed applicant for PiCCO Catheter?

The FDA 510(k) record lists Pulsion Medical Systems SE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PiCCO Catheter?

The FDA product code for PiCCO Catheter is KRB.

Other records listing Pulsion Medical Systems SE as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192169PulsioFlex Monitoring System with ProAQT SensorK172259PulsioFlex Monitoring System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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