FDA 510(k)

Firefly Needleless Connector

K-Number: K203796 · 2021-07-30

Decision Date2021-07-30

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Firefly Needleless Connector is a medical device manufactured by Puracath Medical, Inc.. It received FDA 510(k) clearance on 2021-07-30 under approval number K203796. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firefly Needleless Connector?

Firefly Needleless Connector is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Puracath Medical, Inc.. The 510(k) number is K203796.

When was Firefly Needleless Connector approved by the FDA?

Firefly Needleless Connector received FDA 510(k) clearance on 2021-07-30, under approval number K203796.

What company makes Firefly Needleless Connector?

Firefly Needleless Connector is manufactured by Puracath Medical, Inc..

What is the FDA product code for Firefly Needleless Connector?

The FDA product code for Firefly Needleless Connector is FPA.

Other Devices by Puracath Medical, Inc.

K151620Firefly Peritoneal Dialysis Connector Disinfection System K251375PuraCath Firefly Needleless Connector IT (9005)

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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.