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FDA 510(k)

PiCCO Catheter

K-Number: K171620 · 2018-02-21

Decision Date2018-02-21
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PiCCO Catheter is a medical device manufactured by Pulsion Medical Systems SE. It received FDA 510(k) clearance on 2018-02-21 under approval 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. It is manufactured by Pulsion Medical Systems SE. The 510(k) number is K171620.

When was PiCCO Catheter approved by the FDA?

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

What company makes PiCCO Catheter?

PiCCO Catheter is manufactured by Pulsion Medical Systems SE.

What is the FDA product code for PiCCO Catheter?

The FDA product code for PiCCO Catheter is KRB.

Other Devices by Pulsion Medical Systems SE

Official Source

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