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FDA 510(k)

MitraClip G4 Steerable Guide Catheter

K-Number: K190167 · 2019-05-29

ApplicantAbbott
Decision Date2019-05-29
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MitraClip G4 Steerable Guide Catheter is a medical device manufactured by Abbott. It received FDA 510(k) clearance on 2019-05-29 under approval number K190167. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MitraClip G4 Steerable Guide Catheter?

MitraClip G4 Steerable Guide Catheter is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Abbott. The 510(k) number is K190167.

When was MitraClip G4 Steerable Guide Catheter approved by the FDA?

MitraClip G4 Steerable Guide Catheter received FDA 510(k) clearance on 2019-05-29, under approval number K190167.

What company makes MitraClip G4 Steerable Guide Catheter?

MitraClip G4 Steerable Guide Catheter is manufactured by Abbott.

What is the FDA product code for MitraClip G4 Steerable Guide Catheter?

The FDA product code for MitraClip G4 Steerable Guide Catheter is DRA.

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Related Devices (Code: DRA)

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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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