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FDA 510(k)

CAPIOX HEMOCONCENTRATOR

K-Number: K973516 · 1998-01-30

ApplicantTerumo Medical Corp.
Decision Date1998-01-30
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAPIOX HEMOCONCENTRATOR 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 1998-01-30 under 510(k) number K973516. 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 CAPIOX HEMOCONCENTRATOR?

CAPIOX HEMOCONCENTRATOR is a medical device that received FDA 510(k) clearance on 1998-01-30. The listed applicant is Terumo Medical Corp.. The 510(k) number is K973516.

When did CAPIOX HEMOCONCENTRATOR receive FDA 510(k) clearance?

CAPIOX HEMOCONCENTRATOR received FDA 510(k) clearance on 1998-01-30, under 510(k) number K973516.

Who is the listed applicant for CAPIOX HEMOCONCENTRATOR?

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 CAPIOX HEMOCONCENTRATOR?

The FDA product code for CAPIOX HEMOCONCENTRATOR 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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