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FDA 510(k)

MAGIC Infusion Catheter

K-Number: K202366 · 2021-01-29

ApplicantBalt USA, LLC
Decision Date2021-01-29
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAGIC Infusion Catheter 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 2021-01-29 under 510(k) number K202366. 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 Infusion Catheter?

MAGIC Infusion Catheter is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Balt USA, LLC. The 510(k) number is K202366.

When did MAGIC Infusion Catheter receive FDA 510(k) clearance?

MAGIC Infusion Catheter received FDA 510(k) clearance on 2021-01-29, under 510(k) number K202366.

Who is the listed applicant for MAGIC Infusion Catheter?

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 Infusion Catheter?

The FDA product code for MAGIC Infusion Catheter is KRA.

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Other records listing Balt USA, LLC as applicant

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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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