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FDA 510(k)

CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

K-Number: K031920 · 2003-07-23

ApplicantTrans Vascular Incorporated
Decision Date2003-07-23
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 is the device name listed in this FDA 510(k) record. The listed applicant is Trans Vascular Incorporated. It received FDA 510(k) clearance on 2003-07-23 under 510(k) number K031920. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001?

CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 is a medical device that received FDA 510(k) clearance on 2003-07-23. The listed applicant is Trans Vascular Incorporated. The 510(k) number is K031920.

When did CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 receive FDA 510(k) clearance?

CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 received FDA 510(k) clearance on 2003-07-23, under 510(k) number K031920.

Who is the listed applicant for CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001?

The FDA 510(k) record lists Trans Vascular Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001?

The FDA product code for CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 is ITX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Trans Vascular Incorporated 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.

K013363CROSSPOINT TRANSACCESS CATHETER

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna 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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