FDA 510(k)

Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)

K-Number: K241370 · 2024-06-13

Decision Date2024-06-13

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-06-13 under approval number K241370. 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 (I-V2-MED)?

Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K241370.

When was Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) approved by the FDA?

Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) received FDA 510(k) clearance on 2024-06-13, under approval number K241370.

What company makes Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)?

Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)?

The FDA product code for Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) 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.