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FDA 510(k)

INPERSOL CAPD BIOCAP ADMINISTRATION SET

K-Number: K911094 · 1991-04-16

ApplicantAbbott Laboratories
Decision Date1991-04-16
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INPERSOL CAPD BIOCAP ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1991-04-16 under 510(k) number K911094. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INPERSOL CAPD BIOCAP ADMINISTRATION SET?

INPERSOL CAPD BIOCAP ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1991-04-16. The listed applicant is Abbott Laboratories. The 510(k) number is K911094.

When did INPERSOL CAPD BIOCAP ADMINISTRATION SET receive FDA 510(k) clearance?

INPERSOL CAPD BIOCAP ADMINISTRATION SET received FDA 510(k) clearance on 1991-04-16, under 510(k) number K911094.

Who is the listed applicant for INPERSOL CAPD BIOCAP ADMINISTRATION SET?

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

What is the FDA product code for INPERSOL CAPD BIOCAP ADMINISTRATION SET?

The FDA product code for INPERSOL CAPD BIOCAP ADMINISTRATION SET is KDI.

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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