FDA 510(k)

ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682

K-Number: K091310 · 2010-08-11

Decision Date2010-08-11

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 is the device name listed in this FDA 510(k) record. The listed applicant is Dfine, Inc.. It received FDA 510(k) clearance on 2010-08-11 under 510(k) number K091310. 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 ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682?

ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 is a medical device that received FDA 510(k) clearance on 2010-08-11. The listed applicant is Dfine, Inc.. The 510(k) number is K091310.

When did ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 receive FDA 510(k) clearance?

ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 received FDA 510(k) clearance on 2010-08-11, under 510(k) number K091310.

Who is the listed applicant for ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682?

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

What is the FDA product code for ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682?

The FDA product code for ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 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.