FDA 510(k)

93 NeuFlex Catheter

K-Number: K251044 · 2025-05-23

Decision Date2025-05-23

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

93 NeuFlex Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Piraeus Medical. It received FDA 510(k) clearance on 2025-05-23 under 510(k) 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. The listed applicant is Piraeus Medical. The 510(k) number is K251044.

When did 93 NeuFlex Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for 93 NeuFlex Catheter?

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

What is the FDA product code for 93 NeuFlex Catheter?

The FDA product code for 93 NeuFlex Catheter is QJP.

Other records listing Piraeus Medical 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.