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FDA 510(k)

CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS

K-Number: K984055 · 1999-01-29

ApplicantSims Deltec, Inc.
Decision Date1999-01-29
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1999-01-29 under 510(k) number K984055. 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 CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS?

CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS is a medical device that received FDA 510(k) clearance on 1999-01-29. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K984055.

When did CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS receive FDA 510(k) clearance?

CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS received FDA 510(k) clearance on 1999-01-29, under 510(k) number K984055.

Who is the listed applicant for CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS?

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

What is the FDA product code for CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS?

The FDA product code for CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS is FOZ.

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Other records listing Sims Deltec, Inc. as applicant

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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

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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