Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0

K-Number: K081515 · 2008-07-21

ApplicantNeomed, Inc.
Decision Date2008-07-21
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Neomed, Inc.. It received FDA 510(k) clearance on 2008-07-21 under 510(k) number K081515. 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 NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0?

NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 is a medical device that received FDA 510(k) clearance on 2008-07-21. The listed applicant is Neomed, Inc.. The 510(k) number is K081515.

When did NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 receive FDA 510(k) clearance?

NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 received FDA 510(k) clearance on 2008-07-21, under 510(k) number K081515.

Who is the listed applicant for NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0?

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

What is the FDA product code for NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0?

The FDA product code for NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 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 Neomed, 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.

K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)K122373NEOMED ORAL/ENTERAL SYRINGEK120182NEOMED GASTROINTESTINAL TUBE AND ACCESSORIESK100288NEOMED ENTERAL ONLY EXTENSION SETK092908NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO

View all 11 devices →

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 MedicalK073596NEOMED SINGLE LUMEN UMBILICAL CATHETERNeomed, 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.

↑