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FDA 510(k)

Firefly Peritoneal Dialysis Connector Disinfection System

K-Number: K151620 · 2016-01-20

ApplicantPuracath Medical, Inc.
Decision Date2016-01-20
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Firefly Peritoneal Dialysis Connector Disinfection System 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 2016-01-20 under 510(k) number K151620. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firefly Peritoneal Dialysis Connector Disinfection System?

Firefly Peritoneal Dialysis Connector Disinfection System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Puracath Medical, Inc.. The 510(k) number is K151620.

When did Firefly Peritoneal Dialysis Connector Disinfection System receive FDA 510(k) clearance?

Firefly Peritoneal Dialysis Connector Disinfection System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K151620.

Who is the listed applicant for Firefly Peritoneal Dialysis Connector Disinfection System?

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 Firefly Peritoneal Dialysis Connector Disinfection System?

The FDA product code for Firefly Peritoneal Dialysis Connector Disinfection System is KDJ.

Other records listing Puracath Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251375PuraCath Firefly Needleless Connector IT (9005)K203796Firefly Needleless Connector

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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