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FDA 510(k)

XO Cross Support Catheter

K-Number: K210322 · 2021-10-21

ApplicantTransit Scientific, LLC
Decision Date2021-10-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XO Cross Support Catheter is a medical device manufactured by Transit Scientific, LLC. It received FDA 510(k) clearance on 2021-10-21 under approval 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. It is manufactured by Transit Scientific, LLC. The 510(k) number is K210322.

When was XO Cross Support Catheter approved by the FDA?

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

What company makes XO Cross Support Catheter?

XO Cross Support Catheter is manufactured by Transit Scientific, LLC.

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

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

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Related PubMed Literature

PMID: 41945713 Strength of Evidence to Support Decision-Making on the Use of Digital Mental Health Technologies in NICE Evaluations: Cross-Sectional Analysis of Studies. JMIR mental health (2026)

Other Devices by Transit Scientific, LLC

K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter K214107XO CROSS CORONARY Support Catheter K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining 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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