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FDA 510(k)

RenaPure Endotoxin Retentive Filter

K-Number: K231410 · 2023-07-19

ApplicantEvoqua Water Technologies, LLC
Decision Date2023-07-19
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RenaPure Endotoxin Retentive Filter is the device name listed in this FDA 510(k) record. The listed applicant is Evoqua Water Technologies, LLC. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231410. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RenaPure Endotoxin Retentive Filter?

RenaPure Endotoxin Retentive Filter is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Evoqua Water Technologies, LLC. The 510(k) number is K231410.

When did RenaPure Endotoxin Retentive Filter receive FDA 510(k) clearance?

RenaPure Endotoxin Retentive Filter received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231410.

Who is the listed applicant for RenaPure Endotoxin Retentive Filter?

The FDA 510(k) record lists Evoqua Water Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RenaPure Endotoxin Retentive Filter?

The FDA product code for RenaPure Endotoxin Retentive Filter is FIP.

Other records listing Evoqua Water Technologies, LLC 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.

K153784NOSOGARD FILTERS

Related Devices (Code: FIP)

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

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.

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