FDA 510(k)

CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT

K-Number: K060400 · 2006-02-28

Decision Date2006-02-28

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2006-02-28 under 510(k) number K060400. 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 SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT?

CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT is a medical device that received FDA 510(k) clearance on 2006-02-28. The listed applicant is Medtronic, Inc.. The 510(k) number is K060400.

When did CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT receive FDA 510(k) clearance?

CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT received FDA 510(k) clearance on 2006-02-28, under 510(k) number K060400.

Who is the listed applicant for CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT?

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

What is the FDA product code for CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT?

The FDA product code for CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT 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.