Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vessel Dilator

K-Number: K163524 · 2017-06-29

Decision Date2017-06-29
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vessel Dilator is a medical device manufactured by Fetzer Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2017-06-29 under approval number K163524. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vessel Dilator?

Vessel Dilator is a medical device that received FDA 510(k) clearance on 2017-06-29. It is manufactured by Fetzer Medical GmbH & Co. KG. The 510(k) number is K163524.

When was Vessel Dilator approved by the FDA?

Vessel Dilator received FDA 510(k) clearance on 2017-06-29, under approval number K163524.

What company makes Vessel Dilator?

Vessel Dilator is manufactured by Fetzer Medical GmbH & Co. KG.

What is the FDA product code for Vessel Dilator?

The FDA product code for Vessel Dilator is DWP.

Other Devices by Fetzer Medical GmbH & Co. KG

Related Devices (Code: DWP)

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.