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FDA 510(k)

Xcess Guiding Catheter

K-Number: K180797 · 2018-12-14

ApplicantCuratia Medical Co.
Decision Date2018-12-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Xcess Guiding Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Curatia Medical Co.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K180797. 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 Xcess Guiding Catheter?

Xcess Guiding Catheter is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Curatia Medical Co.. The 510(k) number is K180797.

When did Xcess Guiding Catheter receive FDA 510(k) clearance?

Xcess Guiding Catheter received FDA 510(k) clearance on 2018-12-14, under 510(k) number K180797.

Who is the listed applicant for Xcess Guiding Catheter?

The FDA 510(k) record lists Curatia Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xcess Guiding Catheter?

The FDA product code for Xcess Guiding Catheter is DQY.

Other records listing Curatia Medical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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