FDA 510(k)

Amplatzer Steerable Delivery Sheath

K-Number: K220340 · 2022-03-09

Decision Date2022-03-09

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Amplatzer Steerable 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 2022-03-09 under 510(k) number K220340. 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 2022-03-09. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K220340.

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

Amplatzer Steerable Delivery Sheath received FDA 510(k) clearance on 2022-03-09, under 510(k) number K220340.

Who is the listed applicant for Amplatzer Steerable 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 Steerable Delivery Sheath?

The FDA product code for Amplatzer Steerable 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.