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FDA 510(k)

CATHETER INSERTION TRAY

K-Number: K922179 · 1993-07-02

ApplicantMedcare Custom Packaging, Inc.
Decision Date1993-07-02
Product CodeFMI
Advisory CommitteeHO
DecisionUnknown

Device Summary

CATHETER INSERTION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Custom Packaging, Inc.. It received FDA 510(k) clearance on 1993-07-02 under 510(k) number K922179. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CATHETER INSERTION TRAY?

CATHETER INSERTION TRAY is a medical device that received FDA 510(k) clearance on 1993-07-02. The listed applicant is Medcare Custom Packaging, Inc.. The 510(k) number is K922179.

When did CATHETER INSERTION TRAY receive FDA 510(k) clearance?

CATHETER INSERTION TRAY received FDA 510(k) clearance on 1993-07-02, under 510(k) number K922179.

Who is the listed applicant for CATHETER INSERTION TRAY?

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

What is the FDA product code for CATHETER INSERTION TRAY?

The FDA product code for CATHETER INSERTION TRAY is FMI.

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Other records listing Medcare Custom Packaging, 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.

K954869MEDCARE YANKAUER SUCTION DEVICEK954442STERILE ISOTONIC SALINE & STERILE WATERK952759TOWEL PACKK950390URETHRAL CATHETERIZATION TRAYK943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERK951149SINGLE USE INSTRUMENT TRAY

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Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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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