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FDA 510(k)

Amulet™ Steerable Delivery Sheath

K-Number: K250426 · 2025-04-25

ApplicantABBOTT MEDICAL
Decision Date2025-04-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amulet™ Steerable Delivery Sheath is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-04-25 under approval number K250426. 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 Amulet™ Steerable Delivery Sheath?

Amulet™ Steerable Delivery Sheath is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K250426.

When was Amulet™ Steerable Delivery Sheath approved by the FDA?

Amulet™ Steerable Delivery Sheath received FDA 510(k) clearance on 2025-04-25, under approval number K250426.

What company makes Amulet™ Steerable Delivery Sheath?

Amulet™ Steerable Delivery Sheath is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Amulet™ Steerable Delivery Sheath?

The FDA product code for Amulet™ Steerable Delivery Sheath is DQY.

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Related Devices (Code: 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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