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FDA 510(k)

NON-STERILE PERITONEAL ACCESS CATHET-

K-Number: K830257 · 1983-02-24

ApplicantEvermed, Inc.
Decision Date1983-02-24
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NON-STERILE PERITONEAL ACCESS CATHET- is the device name listed in this FDA 510(k) record. The listed applicant is Evermed, Inc.. It received FDA 510(k) clearance on 1983-02-24 under 510(k) number K830257. 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 NON-STERILE PERITONEAL ACCESS CATHET-?

NON-STERILE PERITONEAL ACCESS CATHET- is a medical device that received FDA 510(k) clearance on 1983-02-24. The listed applicant is Evermed, Inc.. The 510(k) number is K830257.

When did NON-STERILE PERITONEAL ACCESS CATHET- receive FDA 510(k) clearance?

NON-STERILE PERITONEAL ACCESS CATHET- received FDA 510(k) clearance on 1983-02-24, under 510(k) number K830257.

Who is the listed applicant for NON-STERILE PERITONEAL ACCESS CATHET-?

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

What is the FDA product code for NON-STERILE PERITONEAL ACCESS CATHET-?

The FDA product code for NON-STERILE PERITONEAL ACCESS CATHET- is FKX.

Related Clinical Trials

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Other records listing Evermed, 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.

K840846STERILE HICHMAN/BROVIAC INJECTION CAPK840529STEIGER TUNNELING INSTRUMENT 285K830256NON-STERILE BROVIAC PARENTERAL ALIMI-K830406NON-STERILE CATHETER REPAIR KITSK830233NON-STERILE,SINGLE/SOUBLE LUMEN-CATH

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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