FDA 510(k)

Direxion and Direxion HI-FLO Torqueable Microcatheters

K-Number: K163701 · 2017-05-16

Decision Date2017-05-16

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Direxion and Direxion HI-FLO Torqueable Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K163701. 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 Direxion and Direxion HI-FLO Torqueable Microcatheters?

Direxion and Direxion HI-FLO Torqueable Microcatheters is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Boston Scientific Corporation. The 510(k) number is K163701.

When did Direxion and Direxion HI-FLO Torqueable Microcatheters receive FDA 510(k) clearance?

Direxion and Direxion HI-FLO Torqueable Microcatheters received FDA 510(k) clearance on 2017-05-16, under 510(k) number K163701.

Who is the listed applicant for Direxion and Direxion HI-FLO Torqueable Microcatheters?

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

What is the FDA product code for Direxion and Direxion HI-FLO Torqueable Microcatheters?

The FDA product code for Direxion and Direxion HI-FLO Torqueable Microcatheters is KRA.

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Related Devices (Code: KRA)

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation K250794InVera Infusion DeviceInvera Medical K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited K231821XO 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, LLC K231279Peregrine 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.