FDA 510(k)

Amplatzer Talisman Delivery Sheath

K-Number: K212738 · 2021-09-27

Decision Date2021-09-27

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Amplatzer Talisman Delivery Sheath is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2021-09-27 under 510(k) 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. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K212738.

When did Amplatzer Talisman Delivery Sheath receive FDA 510(k) clearance?

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

Who is the listed applicant for Amplatzer Talisman Delivery Sheath?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Amplatzer Talisman Delivery Sheath is DQY.

Other records listing ABBOTT MEDICAL as applicant

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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.