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FDA 510(k)

Amulet™ Steerable Delivery Sheath

K-Number: K232690 · 2023-09-29

ApplicantABBOTT MEDICAL
Decision Date2023-09-29
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 2023-09-29 under approval number K232690. 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 2023-09-29. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K232690.

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

Amulet™ Steerable Delivery Sheath received FDA 510(k) clearance on 2023-09-29, under approval number K232690.

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)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, Inc.

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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