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FDA 510(k)

Multi-Sideport Catheter Infusion Set

K-Number: K182071 · 2019-04-25

ApplicantCook Incorporated
Decision Date2019-04-25
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multi-Sideport Catheter Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K182071. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multi-Sideport Catheter Infusion Set?

Multi-Sideport Catheter Infusion Set is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Cook Incorporated. The 510(k) number is K182071.

When did Multi-Sideport Catheter Infusion Set receive FDA 510(k) clearance?

Multi-Sideport Catheter Infusion Set received FDA 510(k) clearance on 2019-04-25, under 510(k) number K182071.

Who is the listed applicant for Multi-Sideport Catheter Infusion Set?

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

What is the FDA product code for Multi-Sideport Catheter Infusion Set?

The FDA product code for Multi-Sideport Catheter Infusion Set is KRA.

Related Clinical Trials

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NCT02633124Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.TERMINATED

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Related Devices (Code: KRA)

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.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, 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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