FDA 510(k)

XableCath Crossing Catheter

K-Number: K183357 · 2019-01-21

Decision Date2019-01-21

Product CodePDU

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

XableCath Crossing Catheter is a medical device manufactured by Xablecath, Inc.. It received FDA 510(k) clearance on 2019-01-21 under approval number K183357. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XableCath Crossing Catheter?

XableCath Crossing Catheter is a medical device that received FDA 510(k) clearance on 2019-01-21. It is manufactured by Xablecath, Inc.. The 510(k) number is K183357.

When was XableCath Crossing Catheter approved by the FDA?

XableCath Crossing Catheter received FDA 510(k) clearance on 2019-01-21, under approval number K183357.

What company makes XableCath Crossing Catheter?

XableCath Crossing Catheter is manufactured by Xablecath, Inc..

What is the FDA product code for XableCath Crossing Catheter?

The FDA product code for XableCath Crossing Catheter is PDU.

Other Devices by Xablecath, Inc.

K170041XableCath Support Catheter K180986XableCath Support Catheter Product Family

Related Devices (Code: PDU)

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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.