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FDA 510(k)

NEO-CARE CATHETERIZATION TRAY

K-Number: K963867 · 1996-11-06

ApplicantKlein-Baker Medical, Inc.
Decision Date1996-11-06
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEO-CARE CATHETERIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Klein-Baker Medical, Inc.. It received FDA 510(k) clearance on 1996-11-06 under 510(k) number K963867. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-CARE CATHETERIZATION TRAY?

NEO-CARE CATHETERIZATION TRAY is a medical device that received FDA 510(k) clearance on 1996-11-06. The listed applicant is Klein-Baker Medical, Inc.. The 510(k) number is K963867.

When did NEO-CARE CATHETERIZATION TRAY receive FDA 510(k) clearance?

NEO-CARE CATHETERIZATION TRAY received FDA 510(k) clearance on 1996-11-06, under 510(k) number K963867.

Who is the listed applicant for NEO-CARE CATHETERIZATION TRAY?

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

What is the FDA product code for NEO-CARE CATHETERIZATION TRAY?

The FDA product code for NEO-CARE CATHETERIZATION TRAY is FOZ.

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 Klein-Baker Medical, 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.

K972731NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SETK970997NEO-CARE LUMBER PUNCTURE KITK970434NEO-PICCK963972NEO-CARE DUAL LUMEN UMBILICAL CATHETER

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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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