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FDA 510(k)

VENOFER PUMP

K-Number: K121497 · 2012-08-17

ApplicantRenal Solutions, Inc.
Decision Date2012-08-17
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VENOFER PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Renal Solutions, Inc.. It received FDA 510(k) clearance on 2012-08-17 under 510(k) number K121497. 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 VENOFER PUMP?

VENOFER PUMP is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Renal Solutions, Inc.. The 510(k) number is K121497.

When did VENOFER PUMP receive FDA 510(k) clearance?

VENOFER PUMP received FDA 510(k) clearance on 2012-08-17, under 510(k) number K121497.

Who is the listed applicant for VENOFER PUMP?

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

What is the FDA product code for VENOFER PUMP?

The FDA product code for VENOFER PUMP is KDI.

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Other records listing Renal Solutions, 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.

K1238352008 HEMODIALYSIS SORBENT SYSTEMK103564VENOFER PUMPK0933622008 HEMODIALYSIS SORBENT SYSTEMK093964VENOFER PUMPK070739ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500K060381ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100

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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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