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FDA 510(k)

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter

K-Number: K214025 · 2022-04-12

ApplicantMedos International SARL
Decision Date2022-04-12
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K214025. 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 PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter?

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Medos International SARL. The 510(k) number is K214025.

When did PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter receive FDA 510(k) clearance?

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter received FDA 510(k) clearance on 2022-04-12, under 510(k) number K214025.

Who is the listed applicant for PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter?

The FDA product code for PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter is KRA.

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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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