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FDA 510(k)

PACEART SYSTEM

K-Number: K024278 · 2003-05-29

ApplicantMedtronic Vascular
Decision Date2003-05-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEART SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2003-05-29 under 510(k) number K024278. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACEART SYSTEM?

PACEART SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-29. The listed applicant is Medtronic Vascular. The 510(k) number is K024278.

When did PACEART SYSTEM receive FDA 510(k) clearance?

PACEART SYSTEM received FDA 510(k) clearance on 2003-05-29, under 510(k) number K024278.

Who is the listed applicant for PACEART SYSTEM?

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 PACEART SYSTEM?

The FDA product code for PACEART SYSTEM is DPS.

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Related Devices (Code: DPS)

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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