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FDA 510(k)

Amplatzer Talisman Delivery Sheath

K-Number: K212738 · 2021-09-27

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

Device Summary

Amplatzer Talisman Delivery Sheath is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2021-09-27 under approval number K212738. 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 Talisman Delivery Sheath?

Amplatzer Talisman 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 K212738.

When was Amplatzer Talisman Delivery Sheath approved by the FDA?

Amplatzer Talisman Delivery Sheath received FDA 510(k) clearance on 2021-09-27, under approval number K212738.

What company makes Amplatzer Talisman Delivery Sheath?

Amplatzer Talisman Delivery Sheath is manufactured by ABBOTT MEDICAL.

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

The FDA product code for Amplatzer Talisman 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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