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FDA 510(k)

RHYTHMIA MAPPING CATHETER

K-Number: K122461 · 2013-04-18

ApplicantRhythmia Medical, Inc.
Decision Date2013-04-18
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RHYTHMIA MAPPING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmia Medical, Inc.. It received FDA 510(k) clearance on 2013-04-18 under 510(k) number K122461. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTHMIA MAPPING CATHETER?

RHYTHMIA MAPPING CATHETER is a medical device that received FDA 510(k) clearance on 2013-04-18. The listed applicant is Rhythmia Medical, Inc.. The 510(k) number is K122461.

When did RHYTHMIA MAPPING CATHETER receive FDA 510(k) clearance?

RHYTHMIA MAPPING CATHETER received FDA 510(k) clearance on 2013-04-18, under 510(k) number K122461.

Who is the listed applicant for RHYTHMIA MAPPING CATHETER?

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

What is the FDA product code for RHYTHMIA MAPPING CATHETER?

The FDA product code for RHYTHMIA MAPPING CATHETER is DRF.

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 Rhythmia Medical, 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.

K130750RHYTHMIA MAPPING SYSTEM

Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, 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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