FDA 510(k)

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261

K-Number: K070311 · 2007-04-24

Decision Date2007-04-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2007-04-24 under 510(k) number K070311. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261?

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 is a medical device that received FDA 510(k) clearance on 2007-04-24. The listed applicant is Medtronic Vascular. The 510(k) number is K070311.

When did CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 receive FDA 510(k) clearance?

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 received FDA 510(k) clearance on 2007-04-24, under 510(k) number K070311.

Who is the listed applicant for CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261?

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 GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261?

The FDA product code for CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 is GEI.

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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.