FDA 510(k)

Telescope Guide Extension Catheter

K-Number: K183353 · 2019-03-22

Decision Date2019-03-22

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Telescope Guide Extension Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K183353. 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 Telescope Guide Extension Catheter?

Telescope Guide Extension Catheter is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Medtronic, Inc.. The 510(k) number is K183353.

When did Telescope Guide Extension Catheter receive FDA 510(k) clearance?

Telescope Guide Extension Catheter received FDA 510(k) clearance on 2019-03-22, under 510(k) number K183353.

Who is the listed applicant for Telescope Guide Extension Catheter?

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

What is the FDA product code for Telescope Guide Extension Catheter?

The FDA product code for Telescope Guide Extension Catheter 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.