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FDA 510(k)

Verge™ Microcatheter

K-Number: K261610 · 2026-06-11

ApplicantInstylla, Inc.
Decision Date2026-06-11
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Verge™ Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Instylla, Inc.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K261610. 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 Verge™ Microcatheter?

Verge™ Microcatheter is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Instylla, Inc.. The 510(k) number is K261610.

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

Verge™ Microcatheter received FDA 510(k) clearance on 2026-06-11, under 510(k) number K261610.

Who is the listed applicant for Verge™ Microcatheter?

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

What is the FDA product code for Verge™ Microcatheter?

The FDA product code for Verge™ Microcatheter is KRA.

Related Clinical Trials

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.

NCT04523350Instylla HES Hypervascular Tumor Pivotal StudyCOMPLETED

Other records listing Instylla, Inc. as applicant

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.

PMA P250003Embolization Agent, VascularK253769Instylla Delivery KitK253677Tembo Embolic SystemK240873TEMBO Embolic SystemK213632Instylla Delivery KitK210808Instylla Microcatheter 1.2

View all 11 devices →

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.

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.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.

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