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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 the device name listed in this FDA 510(k) record. The listed applicant is Puracath Medical, Inc.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) 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. The listed applicant is Puracath Medical, Inc.. The 510(k) number is K251375.

When did PuraCath Firefly Needleless Connector IT (9005) receive FDA 510(k) clearance?

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

Who is the listed applicant for PuraCath Firefly Needleless Connector IT (9005)?

The FDA 510(k) record lists Puracath Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Puracath Medical, Inc. as applicant

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Related Devices (Code: 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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