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FDA 510(k)

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.

K-Number: K130725 · 2013-04-17

ApplicantCovidien Lp, Formerly Registered AS Kendall
Decision Date2013-04-17
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. is the device name listed in this FDA 510(k) record. The listed applicant is Covidien Lp, Formerly Registered AS Kendall. It received FDA 510(k) clearance on 2013-04-17 under 510(k) number K130725. 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 MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.?

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. is a medical device that received FDA 510(k) clearance on 2013-04-17. The listed applicant is Covidien Lp, Formerly Registered AS Kendall. The 510(k) number is K130725.

When did MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. receive FDA 510(k) clearance?

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. received FDA 510(k) clearance on 2013-04-17, under 510(k) number K130725.

Who is the listed applicant for MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.?

The FDA 510(k) record lists Covidien Lp, Formerly Registered AS Kendall as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.?

The FDA product code for MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. is FOS.

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Other records listing Covidien Lp, Formerly Registered AS Kendall 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.

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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 CorporationK120304FOOTPRINT 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.K073596NEOMED SINGLE LUMEN UMBILICAL CATHETERNeomed, 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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