FDA 510(k)

XableCath Support Catheter

K-Number: K170041 · 2017-09-07

Decision Date2017-09-07

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

XableCath Support Catheter is a medical device manufactured by Xablecath, Inc.. It received FDA 510(k) clearance on 2017-09-07 under approval number K170041. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XableCath Support Catheter?

XableCath Support Catheter is a medical device that received FDA 510(k) clearance on 2017-09-07. It is manufactured by Xablecath, Inc.. The 510(k) number is K170041.

When was XableCath Support Catheter approved by the FDA?

XableCath Support Catheter received FDA 510(k) clearance on 2017-09-07, under approval number K170041.

What company makes XableCath Support Catheter?

XableCath Support Catheter is manufactured by Xablecath, Inc..

What is the FDA product code for XableCath Support Catheter?

The FDA product code for XableCath Support Catheter is DQY.

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Other Devices by Xablecath, Inc.

K180986XableCath Support Catheter Product Family K183357XableCath Crossing Catheter

Related Devices (Code: DQY)

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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.