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FDA 510(k)

Fusion Quattro Extraction Balloon

K-Number: K200247 · 2020-02-27

ApplicantWilson-Cook Medical, Inc.
Decision Date2020-02-27
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fusion Quattro Extraction Balloon is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2020-02-27 under approval number K200247. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion Quattro Extraction Balloon?

Fusion Quattro Extraction Balloon is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K200247.

When was Fusion Quattro Extraction Balloon approved by the FDA?

Fusion Quattro Extraction Balloon received FDA 510(k) clearance on 2020-02-27, under approval number K200247.

What company makes Fusion Quattro Extraction Balloon?

Fusion Quattro Extraction Balloon is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Fusion Quattro Extraction Balloon?

The FDA product code for Fusion Quattro Extraction Balloon is GCA.

Related PubMed Literature

PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

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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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