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FDA 510(k)

TORAYSULFONE DIALYZER

K-Number: K002512 · 2001-10-15

ApplicantToray Industries (America), Inc.
Decision Date2001-10-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TORAYSULFONE DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Toray Industries (America), Inc.. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K002512. 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 TORAYSULFONE DIALYZER?

TORAYSULFONE DIALYZER is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Toray Industries (America), Inc.. The 510(k) number is K002512.

When did TORAYSULFONE DIALYZER receive FDA 510(k) clearance?

TORAYSULFONE DIALYZER received FDA 510(k) clearance on 2001-10-15, under 510(k) number K002512.

Who is the listed applicant for TORAYSULFONE DIALYZER?

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

What is the FDA product code for TORAYSULFONE DIALYZER?

The FDA product code for TORAYSULFONE DIALYZER is KDI.

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Other records listing Toray Industries (America), 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.

K042370TORAYGUIDE GUIDEWIREK030050TORAYSULFONE DIALYZER, BS-L SERIESK994198HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0LK942681FILTRYZERK935471FILTRYZER(TM)K940910FILTRYZER

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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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