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FDA 510(k)

FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM

K-Number: K902149 · 1990-10-30

ApplicantFresenius/Delmed, Inc.
Decision Date1990-10-30
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius/Delmed, Inc.. It received FDA 510(k) clearance on 1990-10-30 under 510(k) number K902149. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM?

FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1990-10-30. The listed applicant is Fresenius/Delmed, Inc.. The 510(k) number is K902149.

When did FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM receive FDA 510(k) clearance?

FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM received FDA 510(k) clearance on 1990-10-30, under 510(k) number K902149.

Who is the listed applicant for FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM?

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

What is the FDA product code for FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM?

The FDA product code for FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM is FKX.

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Other records listing Fresenius/Delmed, 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.

K90386990/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET

Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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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