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FDA 510(k)

HEMOCATH I KIDNEY DIALYSIS CATHETER

K-Number: K801968 · 1980-09-26

ApplicantMedical Components, Inc.
Decision Date1980-09-26
Product CodeLBW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOCATH I KIDNEY DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K801968. The device is classified under product code LBW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCATH I KIDNEY DIALYSIS CATHETER?

HEMOCATH I KIDNEY DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Medical Components, Inc.. The 510(k) number is K801968.

When did HEMOCATH I KIDNEY DIALYSIS CATHETER receive FDA 510(k) clearance?

HEMOCATH I KIDNEY DIALYSIS CATHETER received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801968.

Who is the listed applicant for HEMOCATH I KIDNEY DIALYSIS CATHETER?

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

What is the FDA product code for HEMOCATH I KIDNEY DIALYSIS CATHETER?

The FDA product code for HEMOCATH I KIDNEY DIALYSIS CATHETER is LBW.

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Other records listing Medical Components, Inc. as applicant

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Related Devices (Code: LBW)

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.

K904433DUAL LUMEN NEEDLESAkcess Medical Products, Inc.K864629MODIFIED DUAL LUMEN NEEDLEQuinton, Inc.K860515DUAL LUMEN NEEDLE (PRODUCT CHANGE)Quinton, Inc.K820859COAXIAL DUAL FLOW CATHETERTerumo Medical Corp.

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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