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FDA 510(k)

CLIRANS E-SERIES DIALYZER

K-Number: K013550 · 2001-11-20

ApplicantTerumo Medical Corp.
Decision Date2001-11-20
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLIRANS E-SERIES DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K013550. 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 CLIRANS E-SERIES DIALYZER?

CLIRANS E-SERIES DIALYZER is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Terumo Medical Corp.. The 510(k) number is K013550.

When did CLIRANS E-SERIES DIALYZER receive FDA 510(k) clearance?

CLIRANS E-SERIES DIALYZER received FDA 510(k) clearance on 2001-11-20, under 510(k) number K013550.

Who is the listed applicant for CLIRANS E-SERIES DIALYZER?

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

What is the FDA product code for CLIRANS E-SERIES DIALYZER?

The FDA product code for CLIRANS E-SERIES DIALYZER is KDI.

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Other records listing Terumo 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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