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FDA 510(k)

PuraCath Firefly Needleless Connector IT (9005)

K-Number: K251375 · 2026-02-12

ApplicantPuracath Medical, Inc.
Decision Date2026-02-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PuraCath Firefly Needleless Connector IT (9005) is a medical device manufactured by Puracath Medical, Inc.. It received FDA 510(k) clearance on 2026-02-12 under approval number K251375. 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 PuraCath Firefly Needleless Connector IT (9005)?

PuraCath Firefly Needleless Connector IT (9005) is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Puracath Medical, Inc.. The 510(k) number is K251375.

When was PuraCath Firefly Needleless Connector IT (9005) approved by the FDA?

PuraCath Firefly Needleless Connector IT (9005) received FDA 510(k) clearance on 2026-02-12, under approval number K251375.

What company makes PuraCath Firefly Needleless Connector IT (9005)?

PuraCath Firefly Needleless Connector IT (9005) is manufactured by Puracath Medical, Inc..

What is the FDA product code for PuraCath Firefly Needleless Connector IT (9005)?

The FDA product code for PuraCath Firefly Needleless Connector IT (9005) is FPA.

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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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