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FDA 510(k)

ACTRIL FOR KIDNEY MACHINE DISINFECTANT

K-Number: K861730 · 1987-06-09

ApplicantRenal Systems, Inc.
Decision Date1987-06-09
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACTRIL FOR KIDNEY MACHINE DISINFECTANT is the device name listed in this FDA 510(k) record. The listed applicant is Renal Systems, Inc.. It received FDA 510(k) clearance on 1987-06-09 under 510(k) number K861730. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTRIL FOR KIDNEY MACHINE DISINFECTANT?

ACTRIL FOR KIDNEY MACHINE DISINFECTANT is a medical device that received FDA 510(k) clearance on 1987-06-09. The listed applicant is Renal Systems, Inc.. The 510(k) number is K861730.

When did ACTRIL FOR KIDNEY MACHINE DISINFECTANT receive FDA 510(k) clearance?

ACTRIL FOR KIDNEY MACHINE DISINFECTANT received FDA 510(k) clearance on 1987-06-09, under 510(k) number K861730.

Who is the listed applicant for ACTRIL FOR KIDNEY MACHINE DISINFECTANT?

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

What is the FDA product code for ACTRIL FOR KIDNEY MACHINE DISINFECTANT?

The FDA product code for ACTRIL FOR KIDNEY MACHINE DISINFECTANT is FKQ.

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Other records listing Renal Systems, 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.

K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)K854011RENALFO HEMOFILTER CAVHDK844790RENAFLO HEMOCONCENTRATORK843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDK844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEMK842258RENATRON

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Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK864635FOUR TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.

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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