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FDA 510(k)

EXPORT ADVANCE ASPIRATION CATHETER

K-Number: K130536 · 2013-07-16

ApplicantMedtronic, Inc.
Decision Date2013-07-16
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXPORT ADVANCE ASPIRATION 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 2013-07-16 under 510(k) number K130536. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPORT ADVANCE ASPIRATION CATHETER?

EXPORT ADVANCE ASPIRATION CATHETER is a medical device that received FDA 510(k) clearance on 2013-07-16. The listed applicant is Medtronic, Inc.. The 510(k) number is K130536.

When did EXPORT ADVANCE ASPIRATION CATHETER receive FDA 510(k) clearance?

EXPORT ADVANCE ASPIRATION CATHETER received FDA 510(k) clearance on 2013-07-16, under 510(k) number K130536.

Who is the listed applicant for EXPORT ADVANCE ASPIRATION 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 EXPORT ADVANCE ASPIRATION CATHETER?

The FDA product code for EXPORT ADVANCE ASPIRATION CATHETER is QEZ.

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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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