FDA 510(k)

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205

K-Number: K090721 · 2009-06-16

Decision Date2009-06-16

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2009-06-16 under 510(k) number K090721. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205?

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 is a medical device that received FDA 510(k) clearance on 2009-06-16. The listed applicant is Medtronic. The 510(k) number is K090721.

When did CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 receive FDA 510(k) clearance?

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 received FDA 510(k) clearance on 2009-06-16, under 510(k) number K090721.

Who is the listed applicant for CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205?

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

What is the FDA product code for CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205?

The FDA product code for CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 is OCL.

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Related Devices (Code: OCL)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.