FDA 510(k)

TriClip Steerable Guide Catheter

K-Number: K241538 · 2024-08-26

Decision Date2024-08-26

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TriClip Steerable Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-08-26 under 510(k) number K241538. 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 TriClip Steerable Guide Catheter?

TriClip Steerable Guide Catheter is a medical device that received FDA 510(k) clearance on 2024-08-26. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K241538.

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

TriClip Steerable Guide Catheter received FDA 510(k) clearance on 2024-08-26, under 510(k) number K241538.

Who is the listed applicant for TriClip Steerable Guide Catheter?

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 TriClip Steerable Guide Catheter?

The FDA product code for TriClip Steerable Guide Catheter is DQY.

Other records listing ABBOTT MEDICAL 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.

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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.