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FDA 510(k)

HCI ALL PURPOSE DRAIN/CATHETER SET

K-Number: K870015 · 1987-02-06

ApplicantHealth Care Innovations, Inc.
Decision Date1987-02-06
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HCI ALL PURPOSE DRAIN/CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Health Care Innovations, Inc.. It received FDA 510(k) clearance on 1987-02-06 under 510(k) number K870015. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HCI ALL PURPOSE DRAIN/CATHETER SET?

HCI ALL PURPOSE DRAIN/CATHETER SET is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Health Care Innovations, Inc.. The 510(k) number is K870015.

When did HCI ALL PURPOSE DRAIN/CATHETER SET receive FDA 510(k) clearance?

HCI ALL PURPOSE DRAIN/CATHETER SET received FDA 510(k) clearance on 1987-02-06, under 510(k) number K870015.

Who is the listed applicant for HCI ALL PURPOSE DRAIN/CATHETER SET?

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

What is the FDA product code for HCI ALL PURPOSE DRAIN/CATHETER SET?

The FDA product code for HCI ALL PURPOSE DRAIN/CATHETER SET is GBS.

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 Health Care Innovations, 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.

K881452FOLDING WHEELCHAIRK872524SAFEWEIGH MAGIC SCALEK872940FOLDING WHEELCHAIRK870014HCI GENERAL PURPOSE CATHETER STYLET

Related Devices (Code: GBS)

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.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.

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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