FDA 510(k)

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES

K-Number: K930218 · 1993-07-27

Decision Date1993-07-27

Product CodeMAJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K930218. The device is classified under product code MAJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES?

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Concord/Portex. The 510(k) number is K930218.

When did SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES receive FDA 510(k) clearance?

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES received FDA 510(k) clearance on 1993-07-27, under 510(k) number K930218.

Who is the listed applicant for SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES?

The FDA 510(k) record lists Concord/Portex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES?

The FDA product code for SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES is MAJ.

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Other records listing Concord/Portex as applicant

K923559STERI-CATH MDI K924541EPIDURAL MINIPACK K930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS K923127NEEDLE-PRO CARTRIDGE K923910HEAT MOISTURE CONDENSER K922749LOW PROFILE TRACHEOSTOMY TUBE

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Related Devices (Code: MAJ)

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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.