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FDA 510(k)

FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER

K-Number: K872767 · 1987-12-29

ApplicantHospal Medical Corp.
Decision Date1987-12-29
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K872767. 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 FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER?

FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Hospal Medical Corp.. The 510(k) number is K872767.

When did FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER receive FDA 510(k) clearance?

FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER received FDA 510(k) clearance on 1987-12-29, under 510(k) number K872767.

Who is the listed applicant for FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER?

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

What is the FDA product code for FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER?

The FDA product code for FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER is KDI.

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Other records listing Hospal Medical Corp. 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.

K893742FILTRAL TM 20 HEMODIALYZER/FILTERK884365MULTIFLOW(TM) 60 KITK884326FILTRAL TM 8 HEMODIALYZERK883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KITK871218MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNITK863961HOSPAL BIOSPAL 1800S

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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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