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FDA 510(k)

SAFE SYTE I.V. CATHETER PLACEMENT UNIT

K-Number: K904648 · 1990-12-14

ApplicantDeseret Medical, Inc.
Decision Date1990-12-14
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE SYTE I.V. CATHETER PLACEMENT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Deseret Medical, Inc.. It received FDA 510(k) clearance on 1990-12-14 under 510(k) number K904648. 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 SAFE SYTE I.V. CATHETER PLACEMENT UNIT?

SAFE SYTE I.V. CATHETER PLACEMENT UNIT is a medical device that received FDA 510(k) clearance on 1990-12-14. The listed applicant is Deseret Medical, Inc.. The 510(k) number is K904648.

When did SAFE SYTE I.V. CATHETER PLACEMENT UNIT receive FDA 510(k) clearance?

SAFE SYTE I.V. CATHETER PLACEMENT UNIT received FDA 510(k) clearance on 1990-12-14, under 510(k) number K904648.

Who is the listed applicant for SAFE SYTE I.V. CATHETER PLACEMENT UNIT?

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

What is the FDA product code for SAFE SYTE I.V. CATHETER PLACEMENT UNIT?

The FDA product code for SAFE SYTE I.V. CATHETER PLACEMENT UNIT is FOZ.

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Other records listing Deseret Medical, 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.

K913027VESSEL DILATORK904121VIALON OBTURATORK904122INSYTE-A ARTERIAL CATHETERIZATION UNITK900116DESERET OPTIMA INTRAVASCULAR CATHETERK895735DESERET MULTILUMEN SUBCLAVIAN CATHETERK895734DESERET INTRAVASCULAR CATHETER

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Related Devices (Code: FOZ)

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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