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FDA 510(k)

FlexCath Select Steerable Shealth and Dilator

K-Number: K163268 · 2017-02-02

ApplicantMedtronic Cryocath, LP
Decision Date2017-02-02
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexCath Select Steerable Shealth and Dilator is a medical device manufactured by Medtronic Cryocath, LP. It received FDA 510(k) clearance on 2017-02-02 under approval number K163268. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexCath Select Steerable Shealth and Dilator?

FlexCath Select Steerable Shealth and Dilator is a medical device that received FDA 510(k) clearance on 2017-02-02. It is manufactured by Medtronic Cryocath, LP. The 510(k) number is K163268.

When was FlexCath Select Steerable Shealth and Dilator approved by the FDA?

FlexCath Select Steerable Shealth and Dilator received FDA 510(k) clearance on 2017-02-02, under approval number K163268.

What company makes FlexCath Select Steerable Shealth and Dilator?

FlexCath Select Steerable Shealth and Dilator is manufactured by Medtronic Cryocath, LP.

What is the FDA product code for FlexCath Select Steerable Shealth and Dilator?

The FDA product code for FlexCath Select Steerable Shealth and Dilator is DYB.

Other Devices by Medtronic Cryocath, LP

K183174FlexCath Advance Steerable Sheath and Dilator K202620FlexCath Advance Steerable Sheath and Dilator PMA P020045Cardiac ablation percutaneous catheter PMA P100010Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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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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