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FDA 510(k)

Sphere-9Dx Diagnostic Catheter (AFR-00009)

K-Number: K233433 · 2024-08-07

ApplicantMedtronic
Decision Date2024-08-07
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sphere-9Dx Diagnostic Catheter (AFR-00009) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2024-08-07 under 510(k) number K233433. 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 Sphere-9Dx Diagnostic Catheter (AFR-00009)?

Sphere-9Dx Diagnostic Catheter (AFR-00009) is a medical device that received FDA 510(k) clearance on 2024-08-07. The listed applicant is Medtronic. The 510(k) number is K233433.

When did Sphere-9Dx Diagnostic Catheter (AFR-00009) receive FDA 510(k) clearance?

Sphere-9Dx Diagnostic Catheter (AFR-00009) received FDA 510(k) clearance on 2024-08-07, under 510(k) number K233433.

Who is the listed applicant for Sphere-9Dx Diagnostic Catheter (AFR-00009)?

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

What is the FDA product code for Sphere-9Dx Diagnostic Catheter (AFR-00009)?

The FDA product code for Sphere-9Dx Diagnostic Catheter (AFR-00009) 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.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITINGNCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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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.K241372Advisor™ 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.K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, 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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