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FDA 510(k)

XO Cross Support Catheter

K-Number: K210322 · 2021-10-21

Decision Date2021-10-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XO Cross Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Transit Scientific, LLC. It received FDA 510(k) clearance on 2021-10-21 under 510(k) number K210322. 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 XO Cross Support Catheter?

XO Cross Support Catheter is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Transit Scientific, LLC. The 510(k) number is K210322.

When did XO Cross Support Catheter receive FDA 510(k) clearance?

XO Cross Support Catheter received FDA 510(k) clearance on 2021-10-21, under 510(k) number K210322.

Who is the listed applicant for XO Cross Support Catheter?

The FDA 510(k) record lists Transit Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XO Cross Support Catheter?

The FDA product code for XO Cross Support Catheter is DQY.

Other records listing Transit Scientific, LLC 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.

View all 7 devices →

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.

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.