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FDA 510(k)

NEO-CARE DUAL LUMEN UMBILICAL CATHETER

K-Number: K963972 · 1996-12-24

ApplicantKlein-Baker Medical, Inc.
Decision Date1996-12-24
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEO-CARE DUAL LUMEN UMBILICAL CATHETER 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 1996-12-24 under 510(k) number K963972. The device is classified under product code FOS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-CARE DUAL LUMEN UMBILICAL CATHETER?

NEO-CARE DUAL LUMEN UMBILICAL CATHETER is a medical device that received FDA 510(k) clearance on 1996-12-24. The listed applicant is Klein-Baker Medical, Inc.. The 510(k) number is K963972.

When did NEO-CARE DUAL LUMEN UMBILICAL CATHETER receive FDA 510(k) clearance?

NEO-CARE DUAL LUMEN UMBILICAL CATHETER received FDA 510(k) clearance on 1996-12-24, under 510(k) number K963972.

Who is the listed applicant for NEO-CARE DUAL LUMEN UMBILICAL CATHETER?

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 DUAL LUMEN UMBILICAL CATHETER?

The FDA product code for NEO-CARE DUAL LUMEN UMBILICAL CATHETER is FOS.

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-PICCK963867NEO-CARE CATHETERIZATION TRAY

Related Devices (Code: FOS)

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.

K201697Umbilical Vessels CatheterHaolang Medical USA CorporationK130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.Covidien Lp, Formerly Registered AS KendallK120304FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETERFootprint Medical, Inc.K091214FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETERFootprint MedicalK091213FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENFootprint MedicalK081515NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0Neomed, 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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