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FDA 510(k)

Amplatzer Steerable Delivery Sheath

K-Number: K212026 · 2021-09-27

ApplicantABBOTT MEDICAL
Decision Date2021-09-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amplatzer Steerable Delivery Sheath is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2021-09-27 under approval number K212026. 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 Amplatzer Steerable Delivery Sheath?

Amplatzer Steerable Delivery Sheath is a medical device that received FDA 510(k) clearance on 2021-09-27. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K212026.

When was Amplatzer Steerable Delivery Sheath approved by the FDA?

Amplatzer Steerable Delivery Sheath received FDA 510(k) clearance on 2021-09-27, under approval number K212026.

What company makes Amplatzer Steerable Delivery Sheath?

Amplatzer Steerable Delivery Sheath is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Amplatzer Steerable Delivery Sheath?

The FDA product code for Amplatzer 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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