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FDA 510(k)

Arctx Cool Catheter Set

K-Number: K250632 · 2025-10-30

ApplicantArctx Medical
Decision Date2025-10-30
Product CodePLA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arctx Cool Catheter Set is a medical device manufactured by Arctx Medical. It received FDA 510(k) clearance on 2025-10-30 under approval number K250632. The device is classified under product code PLA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arctx Cool Catheter Set?

Arctx Cool Catheter Set is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Arctx Medical. The 510(k) number is K250632.

When was Arctx Cool Catheter Set approved by the FDA?

Arctx Cool Catheter Set received FDA 510(k) clearance on 2025-10-30, under approval number K250632.

What company makes Arctx Cool Catheter Set?

Arctx Cool Catheter Set is manufactured by Arctx Medical.

What is the FDA product code for Arctx Cool Catheter Set?

The FDA product code for Arctx Cool Catheter Set is PLA.

Related Devices (Code: PLA)

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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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