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FDA 510(k)

CXI Support Catheter

K-Number: K160884 · 2016-11-22

ApplicantCook Incorporated
Decision Date2016-11-22
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CXI Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160884. 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 CXI Support Catheter?

CXI Support Catheter is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Cook Incorporated. The 510(k) number is K160884.

When did CXI Support Catheter receive FDA 510(k) clearance?

CXI Support Catheter received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160884.

Who is the listed applicant for CXI Support Catheter?

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 CXI Support Catheter?

The FDA product code for CXI Support Catheter is KRA.

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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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