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FDA 510(k)

CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE

K-Number: K062727 · 2006-10-11

ApplicantMedtronic Vascular
Decision Date2006-10-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2006-10-11 under 510(k) number K062727. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE?

CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE is a medical device that received FDA 510(k) clearance on 2006-10-11. The listed applicant is Medtronic Vascular. The 510(k) number is K062727.

When did CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE receive FDA 510(k) clearance?

CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE received FDA 510(k) clearance on 2006-10-11, under 510(k) number K062727.

Who is the listed applicant for CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE?

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 CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE?

The FDA product code for CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE is GCJ.

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Related Devices (Code: GCJ)

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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