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FDA 510(k)

Agilis NxT Steerable Introducer Dual-Reach

K-Number: K243493 · 2024-12-13

ApplicantABBOTT MEDICAL
Decision Date2024-12-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Agilis NxT Steerable Introducer Dual-Reach is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-12-13 under approval number K243493. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Agilis NxT Steerable Introducer Dual-Reach?

Agilis NxT Steerable Introducer Dual-Reach is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K243493.

When was Agilis NxT Steerable Introducer Dual-Reach approved by the FDA?

Agilis NxT Steerable Introducer Dual-Reach received FDA 510(k) clearance on 2024-12-13, under approval number K243493.

What company makes Agilis NxT Steerable Introducer Dual-Reach?

Agilis NxT Steerable Introducer Dual-Reach is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Agilis NxT Steerable Introducer Dual-Reach?

The FDA product code for Agilis NxT Steerable Introducer Dual-Reach is DYB.

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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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