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FDA 510(k)

MEDTRONIC EXPORT AP CATHETER

K-Number: K081573 · 2008-06-27

ApplicantMedtronic Vascular
Decision Date2008-06-27
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC EXPORT AP CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K081573. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC EXPORT AP CATHETER?

MEDTRONIC EXPORT AP CATHETER is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Medtronic Vascular. The 510(k) number is K081573.

When did MEDTRONIC EXPORT AP CATHETER receive FDA 510(k) clearance?

MEDTRONIC EXPORT AP CATHETER received FDA 510(k) clearance on 2008-06-27, under 510(k) number K081573.

Who is the listed applicant for MEDTRONIC EXPORT AP CATHETER?

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

What is the FDA product code for MEDTRONIC EXPORT AP CATHETER?

The FDA product code for MEDTRONIC EXPORT AP CATHETER is DXE.

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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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Other records listing Medtronic Vascular as applicant

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Related Devices (Code: DXE)

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.

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