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FDA 510(k)

CATHETER, UMBILICAR ARTERY

K-Number: K771022 · 1977-11-29

ApplicantAxiom Medical, Inc.
Decision Date1977-11-29
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CATHETER, UMBILICAR ARTERY is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1977-11-29 under 510(k) number K771022. 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 CATHETER, UMBILICAR ARTERY?

CATHETER, UMBILICAR ARTERY is a medical device that received FDA 510(k) clearance on 1977-11-29. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K771022.

When did CATHETER, UMBILICAR ARTERY receive FDA 510(k) clearance?

CATHETER, UMBILICAR ARTERY received FDA 510(k) clearance on 1977-11-29, under 510(k) number K771022.

Who is the listed applicant for CATHETER, UMBILICAR ARTERY?

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

What is the FDA product code for CATHETER, UMBILICAR ARTERY?

The FDA product code for CATHETER, UMBILICAR ARTERY is FOS.

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Other records listing Axiom 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.

K993592AXIOM MULTIPURPOSE WOUND DRAINK971851INTERPLEURAL ANESTHESIA CATHETERK965146FLAT CLOSED WOUND DRAIN WITH TROCARK934895GLASSMAN SILICONE CATHETERK922760ATRAUM WOUND DRESSING--MODIFICATIONK905422PVC ROUND WOUND DRAINS

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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

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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