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FDA 510(k)

Seclusion Catheter

K-Number: K243436 · 2025-02-28

ApplicantBasis Medical
Decision Date2025-02-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Seclusion Catheter is a medical device manufactured by Basis Medical. It received FDA 510(k) clearance on 2025-02-28 under approval number K243436. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Seclusion Catheter?

Seclusion Catheter is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Basis Medical. The 510(k) number is K243436.

When was Seclusion Catheter approved by the FDA?

Seclusion Catheter received FDA 510(k) clearance on 2025-02-28, under approval number K243436.

What company makes Seclusion Catheter?

Seclusion Catheter is manufactured by Basis Medical.

What is the FDA product code for Seclusion Catheter?

The FDA product code for Seclusion Catheter is DQY.

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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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