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FDA 510(k)

SH14 HEMOCONCENTRATOR

K-Number: K081313 · 2008-11-19

ApplicantSorin Group Italia S.R.L.
Decision Date2008-11-19
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SH14 HEMOCONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2008-11-19 under 510(k) number K081313. 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 SH14 HEMOCONCENTRATOR?

SH14 HEMOCONCENTRATOR is a medical device that received FDA 510(k) clearance on 2008-11-19. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K081313.

When did SH14 HEMOCONCENTRATOR receive FDA 510(k) clearance?

SH14 HEMOCONCENTRATOR received FDA 510(k) clearance on 2008-11-19, under 510(k) number K081313.

Who is the listed applicant for SH14 HEMOCONCENTRATOR?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SH14 HEMOCONCENTRATOR?

The FDA product code for SH14 HEMOCONCENTRATOR is KDI.

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Other records listing Sorin Group Italia S.R.L. as applicant

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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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