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FDA 510(k)

CenterCross Ultra Catheter

K-Number: K160681 · 2016-06-17

ApplicantRoxwood Medical, Inc.
Decision Date2016-06-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CenterCross Ultra Catheter is a medical device manufactured by Roxwood Medical, Inc.. It received FDA 510(k) clearance on 2016-06-17 under approval number K160681. 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 CenterCross Ultra Catheter?

CenterCross Ultra Catheter is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Roxwood Medical, Inc.. The 510(k) number is K160681.

When was CenterCross Ultra Catheter approved by the FDA?

CenterCross Ultra Catheter received FDA 510(k) clearance on 2016-06-17, under approval number K160681.

What company makes CenterCross Ultra Catheter?

CenterCross Ultra Catheter is manufactured by Roxwood Medical, Inc..

What is the FDA product code for CenterCross Ultra Catheter?

The FDA product code for CenterCross Ultra Catheter is DQY.

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Other Devices by Roxwood Medical, Inc.

K152957MultiCross Catheter K152456CenterCross Ultra Catheter K170403CenterCross Ultra LV Catheter

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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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