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FDA 510(k)

HEMO-CATH II KIDNEY DIALYSIS CATHETER

K-Number: K801966 · 1980-09-26

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

Device Summary

HEMO-CATH II 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 K801966. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-CATH II KIDNEY DIALYSIS CATHETER?

HEMO-CATH II 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 K801966.

When did HEMO-CATH II KIDNEY DIALYSIS CATHETER receive FDA 510(k) clearance?

HEMO-CATH II KIDNEY DIALYSIS CATHETER received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801966.

Who is the listed applicant for HEMO-CATH II 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 HEMO-CATH II KIDNEY DIALYSIS CATHETER?

The FDA product code for HEMO-CATH II KIDNEY DIALYSIS CATHETER is FIE.

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Related Devices (Code: FIE)

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K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLCK251877JMS CAVEO A.V. Fistula Needle SetJMS North America CorporationK213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.

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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