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FDA 510(k)

HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES

K-Number: K863720 · 1986-10-29

ApplicantWater Pure, Inc.
Decision Date1986-10-29
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Water Pure, Inc.. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K863720. 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 HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES?

HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Water Pure, Inc.. The 510(k) number is K863720.

When did HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES receive FDA 510(k) clearance?

HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES received FDA 510(k) clearance on 1986-10-29, under 510(k) number K863720.

Who is the listed applicant for HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES?

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

What is the FDA product code for HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES?

The FDA product code for HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES is FIP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Water Pure, 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.

K873487HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES

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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