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FDA 510(k)

93 NeuFlex Catheter

K-Number: K251044 · 2025-05-23

ApplicantPiraeus Medical
Decision Date2025-05-23
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

93 NeuFlex Catheter is a medical device manufactured by Piraeus Medical. It received FDA 510(k) clearance on 2025-05-23 under approval number K251044. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 93 NeuFlex Catheter?

93 NeuFlex Catheter is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Piraeus Medical. The 510(k) number is K251044.

When was 93 NeuFlex Catheter approved by the FDA?

93 NeuFlex Catheter received FDA 510(k) clearance on 2025-05-23, under approval number K251044.

What company makes 93 NeuFlex Catheter?

93 NeuFlex Catheter is manufactured by Piraeus Medical.

What is the FDA product code for 93 NeuFlex Catheter?

The FDA product code for 93 NeuFlex Catheter is QJP.

Other Devices by Piraeus Medical

K24097187 NeuGlide Catheter

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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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