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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 the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-12-13 under 510(k) 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. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K243493.

When did Agilis NxT Steerable Introducer Dual-Reach receive FDA 510(k) clearance?

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

Who is the listed applicant for Agilis NxT Steerable Introducer Dual-Reach?

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

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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Related Devices (Code: DYB)

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

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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