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FDA 510(k)

CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS

K-Number: K964041 · 1997-01-30

ApplicantRobert R. Stevens
Decision Date1997-01-30
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Robert R. Stevens. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K964041. 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 CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS?

CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Robert R. Stevens. The 510(k) number is K964041.

When did CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS receive FDA 510(k) clearance?

CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS received FDA 510(k) clearance on 1997-01-30, under 510(k) number K964041.

Who is the listed applicant for CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS?

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

What is the FDA product code for CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS?

The FDA product code for CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS is KOC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Robert R. Stevens 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.

K955270TAPE & BANDAGE, ADHESIVE

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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