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)

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

K-Number: K120425 · 2012-05-24

ApplicantBiosense Webster, Inc.
Decision Date2012-05-24
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER 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 2012-05-24 under 510(k) number K120425. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTARAY NAV HIGH-DENSITY MAPPING CATHETER?

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K120425.

When did PENTARAY NAV HIGH-DENSITY MAPPING CATHETER receive FDA 510(k) clearance?

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER received FDA 510(k) clearance on 2012-05-24, under 510(k) number K120425.

Who is the listed applicant for PENTARAY NAV HIGH-DENSITY MAPPING CATHETER?

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 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER?

The FDA product code for PENTARAY NAV HIGH-DENSITY MAPPING CATHETER is MTD.

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: MTD)

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.

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MedtronicK241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICALK231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Ablacath™ Mapping CatheterAblacon, 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.

↑