MitraClip G4 Steerable Guide Catheter
K-Number: K221397 · 2022-09-28
ApplicantABBOTT MEDICAL
Decision Date2022-09-28
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MitraClip G4 Steerable Guide Catheter is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2022-09-28 under approval number K221397. 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 2022-09-28. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K221397.
When was MitraClip G4 Steerable Guide Catheter approved by the FDA?
MitraClip G4 Steerable Guide Catheter received FDA 510(k) clearance on 2022-09-28, under approval number K221397.
What company makes MitraClip G4 Steerable Guide Catheter?
MitraClip G4 Steerable Guide Catheter is manufactured by ABBOTT MEDICAL.
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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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.