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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 a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2022-04-12 under approval 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. It is manufactured by Medos International SARL. The 510(k) number is K214025.

When was PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter approved by the FDA?

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

What company makes PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter?

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter is manufactured by Medos International SARL.

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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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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