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FDA 510(k)

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

K-Number: K003616 · 2000-12-12

ApplicantBaxter Healthcare Corp
Decision Date2000-12-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2000-12-12 under 510(k) number K003616. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP?

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2000-12-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K003616.

When did COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP receive FDA 510(k) clearance?

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP received FDA 510(k) clearance on 2000-12-12, under 510(k) number K003616.

Who is the listed applicant for COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP?

The FDA product code for COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP is FRN.

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Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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