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FDA 510(k)

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00

K-Number: K090682 · 2009-11-19

ApplicantEdwards Lifesciences Services GmbH
Decision Date2009-11-19
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences Services GmbH. It received FDA 510(k) clearance on 2009-11-19 under 510(k) number K090682. 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 EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00?

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 is a medical device that received FDA 510(k) clearance on 2009-11-19. The listed applicant is Edwards Lifesciences Services GmbH. The 510(k) number is K090682.

When did EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 receive FDA 510(k) clearance?

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 received FDA 510(k) clearance on 2009-11-19, under 510(k) number K090682.

Who is the listed applicant for EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00?

The FDA 510(k) record lists Edwards Lifesciences Services GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00?

The FDA product code for EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 is KDI.

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Other records listing Edwards Lifesciences Services GmbH 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.

K070320EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01K063293EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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