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FDA 510(k)

ONE-SITE IV CONNECTOR

K-Number: K932789 · 1994-07-28

ApplicantCare Medical Devices, Inc.
Decision Date1994-07-28
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ONE-SITE IV CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Care Medical Devices, Inc.. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K932789. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE-SITE IV CONNECTOR?

ONE-SITE IV CONNECTOR is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is Care Medical Devices, Inc.. The 510(k) number is K932789.

When did ONE-SITE IV CONNECTOR receive FDA 510(k) clearance?

ONE-SITE IV CONNECTOR received FDA 510(k) clearance on 1994-07-28, under 510(k) number K932789.

Who is the listed applicant for ONE-SITE IV CONNECTOR?

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

What is the FDA product code for ONE-SITE IV CONNECTOR?

The FDA product code for ONE-SITE IV CONNECTOR is FOZ.

Related Clinical Trials

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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Other records listing Care Medical Devices, 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.

K913914PROGUARDII(TM) BLOOD COLLECTION DEVICE

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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