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FDA 510(k)

XO Cross Support Catheter

K-Number: K193420 · 2020-05-06

ApplicantTransit Scientific
Decision Date2020-05-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XO Cross Support Catheter is a medical device manufactured by Transit Scientific. It received FDA 510(k) clearance on 2020-05-06 under approval number K193420. 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 2020-05-06. It is manufactured by Transit Scientific. The 510(k) number is K193420.

When was XO Cross Support Catheter approved by the FDA?

XO Cross Support Catheter received FDA 510(k) clearance on 2020-05-06, under approval number K193420.

What company makes XO Cross Support Catheter?

XO Cross Support Catheter is manufactured by Transit Scientific.

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: 32986074 Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications. JAMA internal medicine (2020)

Other Devices by Transit Scientific

K193495XO Score Percutaneous Transluminal Angioplasty Scoring 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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