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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2019-05-29 under 510(k) 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. The listed applicant is Abbott. The 510(k) number is K190167.

When did MitraClip G4 Steerable Guide Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for MitraClip G4 Steerable Guide Catheter?

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

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

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

Other records listing Abbott as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 14 devices →

Related Devices (Code: DRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.