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FDA 510(k)

MAGIC Flow-Dependent Microcatheter

K-Number: K213435 · 2022-07-19

ApplicantBalt USA, LLC
Decision Date2022-07-19
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAGIC Flow-Dependent Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2022-07-19 under 510(k) number K213435. 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 MAGIC Flow-Dependent Microcatheter?

MAGIC Flow-Dependent Microcatheter is a medical device that received FDA 510(k) clearance on 2022-07-19. The listed applicant is Balt USA, LLC. The 510(k) number is K213435.

When did MAGIC Flow-Dependent Microcatheter receive FDA 510(k) clearance?

MAGIC Flow-Dependent Microcatheter received FDA 510(k) clearance on 2022-07-19, under 510(k) number K213435.

Who is the listed applicant for MAGIC Flow-Dependent Microcatheter?

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

What is the FDA product code for MAGIC Flow-Dependent Microcatheter?

The FDA product code for MAGIC Flow-Dependent 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.

NCT04410146The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)COMPLETEDNCT07225075Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)RECRUITING

Other records listing Balt USA, LLC 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.

K260199SLIM MicrocatheterK254223Next Generation 088 CatheterPMA P250009Neurovascular Liquid Embolic AgentK254221Optima Coil System (OptiOne Coil System)K252569Carrier XL Delivery CatheterK252700Optima Coil System (Optima Packing Coil System)

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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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