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FDA 510(k)

AMICON DIAFILTER HEMOFILTER

K-Number: K863823 · 1986-11-06

ApplicantAmicon, Inc.
Decision Date1986-11-06
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMICON DIAFILTER HEMOFILTER is the device name listed in this FDA 510(k) record. The listed applicant is Amicon, Inc.. It received FDA 510(k) clearance on 1986-11-06 under 510(k) number K863823. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICON DIAFILTER HEMOFILTER?

AMICON DIAFILTER HEMOFILTER is a medical device that received FDA 510(k) clearance on 1986-11-06. The listed applicant is Amicon, Inc.. The 510(k) number is K863823.

When did AMICON DIAFILTER HEMOFILTER receive FDA 510(k) clearance?

AMICON DIAFILTER HEMOFILTER received FDA 510(k) clearance on 1986-11-06, under 510(k) number K863823.

Who is the listed applicant for AMICON DIAFILTER HEMOFILTER?

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

What is the FDA product code for AMICON DIAFILTER HEMOFILTER?

The FDA product code for AMICON DIAFILTER HEMOFILTER is KDI.

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Other records listing Amicon, 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.

K930168CENTRICON -50 CONCENTRATORK902837AMICON DIAFILTER 30 HEMOCONCENTRATORK901286AMICON HEMOCONCENTRATOR SETK900280CENTRIPREP 100K895405AMICON MINIFILTER PLUS HEMOFILTERK893733CENTRICON CONCENTRATOR

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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