FDA 510(k)

SAFETY NEEDLE SHEATH, MODIFICATION

K-Number: K911037 · 1991-05-03

Decision Date1991-05-03

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFETY NEEDLE SHEATH, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1991-05-03 under 510(k) number K911037. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFETY NEEDLE SHEATH, MODIFICATION?

SAFETY NEEDLE SHEATH, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-05-03. The listed applicant is Concord/Portex. The 510(k) number is K911037.

When did SAFETY NEEDLE SHEATH, MODIFICATION receive FDA 510(k) clearance?

SAFETY NEEDLE SHEATH, MODIFICATION received FDA 510(k) clearance on 1991-05-03, under 510(k) number K911037.

Who is the listed applicant for SAFETY NEEDLE SHEATH, MODIFICATION?

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 SAFETY NEEDLE SHEATH, MODIFICATION?

The FDA product code for SAFETY NEEDLE SHEATH, MODIFICATION is FMI.

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Other records listing Concord/Portex as applicant

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Related Devices (Code: FMI)

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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.