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FDA 510(k)

CATHETER, KIDNEY DIALYSIS, HEMO-CATH II

K-Number: K770552 · 1977-03-30

ApplicantMedical Disposables Intl., Inc.
Decision Date1977-03-30
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER, KIDNEY DIALYSIS, HEMO-CATH II is the device name listed in this FDA 510(k) record. The listed applicant is Medical Disposables Intl., Inc.. It received FDA 510(k) clearance on 1977-03-30 under 510(k) number K770552. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, KIDNEY DIALYSIS, HEMO-CATH II?

CATHETER, KIDNEY DIALYSIS, HEMO-CATH II is a medical device that received FDA 510(k) clearance on 1977-03-30. The listed applicant is Medical Disposables Intl., Inc.. The 510(k) number is K770552.

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

CATHETER, KIDNEY DIALYSIS, HEMO-CATH II received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770552.

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

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

What is the FDA product code for CATHETER, KIDNEY DIALYSIS, HEMO-CATH II?

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

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Other records listing Medical Disposables Intl., 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.

K771231ARTEOIAL LINE KITK771230PERCUTANEOUS INTRODUCER SHEATH SETK770945POUCH, TYVEK-POLYMYLONK770699NEEDLE SET, A-V FISTULAK761078HEMO-CATH I, KIDNEY DIALYSIS CATHETER

Related Devices (Code: KOC)

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.

K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUNIKKISO CO., LTD.K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)NIKKISO CO., LTD.K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD.K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLCK172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC

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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