FDA 510(k)

TruSelect™ 2.6 Microcatheter

K-Number: K260771 · 2026-05-15

Decision Date2026-05-15

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TruSelect™ 2.6 Microcatheter 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 2026-05-15 under 510(k) number K260771. 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 TruSelect™ 2.6 Microcatheter?

TruSelect™ 2.6 Microcatheter is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260771.

When did TruSelect™ 2.6 Microcatheter receive FDA 510(k) clearance?

TruSelect™ 2.6 Microcatheter received FDA 510(k) clearance on 2026-05-15, under 510(k) number K260771.

Who is the listed applicant for TruSelect™ 2.6 Microcatheter?

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 TruSelect™ 2.6 Microcatheter?

The FDA product code for TruSelect™ 2.6 Microcatheter is KRA.

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Related Devices (Code: KRA)

K261610Verge™ MicrocatheterInstylla, Inc.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.K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd.

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.