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FDA 510(k)

RENAL SYSTEMS PERITONEAL ACCESS SYSTEM

K-Number: K844108 · 1985-01-07

ApplicantRenal Systems, Inc.
Decision Date1985-01-07
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAL SYSTEMS PERITONEAL ACCESS SYSTEM 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 1985-01-07 under 510(k) number K844108. 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 RENAL SYSTEMS PERITONEAL ACCESS SYSTEM?

RENAL SYSTEMS PERITONEAL ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1985-01-07. The listed applicant is Renal Systems, Inc.. The 510(k) number is K844108.

When did RENAL SYSTEMS PERITONEAL ACCESS SYSTEM receive FDA 510(k) clearance?

RENAL SYSTEMS PERITONEAL ACCESS SYSTEM received FDA 510(k) clearance on 1985-01-07, under 510(k) number K844108.

Who is the listed applicant for RENAL SYSTEMS PERITONEAL ACCESS SYSTEM?

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 RENAL SYSTEMS PERITONEAL ACCESS SYSTEM?

The FDA product code for RENAL SYSTEMS PERITONEAL ACCESS SYSTEM is FKX.

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Other records listing Renal Systems, 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.

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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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