FDA 510(k)

MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)

K-Number: K243224 · 2024-12-31

Decision Date2024-12-31

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-12-31 under approval number K243224. 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 MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)?

MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) is a medical device that received FDA 510(k) clearance on 2024-12-31. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K243224.

When was MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) approved by the FDA?

MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) received FDA 510(k) clearance on 2024-12-31, under approval number K243224.

What company makes MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)?

MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) is manufactured by ABBOTT MEDICAL.

What is the FDA product code for MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)?

The FDA product code for MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) is 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.