Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM

K-Number: K020863 · 2003-01-09

ApplicantBiosense Webster, Inc.
Decision Date2003-01-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2003-01-09 under 510(k) number K020863. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM?

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-09. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K020863.

When did CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM receive FDA 510(k) clearance?

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM received FDA 510(k) clearance on 2003-01-09, under 510(k) number K020863.

Who is the listed applicant for CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM?

The FDA 510(k) record lists Biosense Webster, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM?

The FDA product code for CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM is DQK.

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 Biosense Webster, Inc. 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.

K252972CARTO™ 3 EP Navigation System V8.4K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusK252302CARTO™ 3 EP Navigation System V8.1K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterK240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterK231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

View all 71 devices →

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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.

↑