FDA 510(k)

PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM

K-Number: K033686 · 2004-01-23

Decision Date2004-01-23

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical MD, Inc.. It received FDA 510(k) clearance on 2004-01-23 under 510(k) number K033686. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM?

PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-23. The listed applicant is Smiths Medical MD, Inc.. The 510(k) number is K033686.

When did PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM receive FDA 510(k) clearance?

PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM received FDA 510(k) clearance on 2004-01-23, under 510(k) number K033686.

Who is the listed applicant for PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM?

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

What is the FDA product code for PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM?

The FDA product code for PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM is LJT.

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Related Devices (Code: LJT)

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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.