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FDA 510(k)

XableCath Support Catheter Product Family

K-Number: K180986 · 2018-05-15

ApplicantXablecath, Inc.
Decision Date2018-05-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XableCath Support Catheter Product Family is a medical device manufactured by Xablecath, Inc.. It received FDA 510(k) clearance on 2018-05-15 under approval number K180986. 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 Product Family?

XableCath Support Catheter Product Family is a medical device that received FDA 510(k) clearance on 2018-05-15. It is manufactured by Xablecath, Inc.. The 510(k) number is K180986.

When was XableCath Support Catheter Product Family approved by the FDA?

XableCath Support Catheter Product Family received FDA 510(k) clearance on 2018-05-15, under approval number K180986.

What company makes XableCath Support Catheter Product Family?

XableCath Support Catheter Product Family is manufactured by Xablecath, Inc..

What is the FDA product code for XableCath Support Catheter Product Family?

The FDA product code for XableCath Support Catheter Product Family is DQY.

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Related PubMed Literature

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Other Devices by Xablecath, Inc.

K170041XableCath Support Catheter K183357XableCath Crossing Catheter

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, Inc.

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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