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FDA 510(k)

HOLLOW FIBER DIALYZER HOLDER

K-Number: K802075 · 1980-09-16

ApplicantRenal Devices, Inc.
Decision Date1980-09-16
Product CodeFKI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER DIALYZER HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Renal Devices, Inc.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K802075. The device is classified under product code FKI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLLOW FIBER DIALYZER HOLDER?

HOLLOW FIBER DIALYZER HOLDER is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Renal Devices, Inc.. The 510(k) number is K802075.

When did HOLLOW FIBER DIALYZER HOLDER receive FDA 510(k) clearance?

HOLLOW FIBER DIALYZER HOLDER received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802075.

Who is the listed applicant for HOLLOW FIBER DIALYZER HOLDER?

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

What is the FDA product code for HOLLOW FIBER DIALYZER HOLDER?

The FDA product code for HOLLOW FIBER DIALYZER HOLDER is FKI.

Related Clinical Trials

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Other records listing Renal Devices, 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.

K810612HEMOPHRONK801559HOLLO FIBER DIALYZERK790696RDI-1 HOLLOW FIBER DIALYZER

Related Devices (Code: FKI)

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.

K843504AMER. BENTLEY HEMOFILTER HOLDER HFH-1American BentleyK811292PARALLEL PLATE DIALYZER HOLDERExtracorporeal Medical Specialities, Inc.

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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