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FDA 510(k)

IMPRA PERITONEAL CATHETER

K-Number: K823857 · 1983-01-26

ApplicantImpra, Inc.
Decision Date1983-01-26
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMPRA PERITONEAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K823857. 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 IMPRA PERITONEAL CATHETER?

IMPRA PERITONEAL CATHETER is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Impra, Inc.. The 510(k) number is K823857.

When did IMPRA PERITONEAL CATHETER receive FDA 510(k) clearance?

IMPRA PERITONEAL CATHETER received FDA 510(k) clearance on 1983-01-26, under 510(k) number K823857.

Who is the listed applicant for IMPRA PERITONEAL CATHETER?

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

What is the FDA product code for IMPRA PERITONEAL CATHETER?

The FDA product code for IMPRA PERITONEAL CATHETER is FKX.

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Other records listing Impra, Inc. as applicant

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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

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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