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FDA 510(k)

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™

K-Number: K241372 · 2024-07-09

ApplicantABBOTT MEDICAL
Decision Date2024-07-09
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-07-09 under 510(k) number K241372. 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 Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™?

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ is a medical device that received FDA 510(k) clearance on 2024-07-09. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K241372.

When did Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ receive FDA 510(k) clearance?

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ received FDA 510(k) clearance on 2024-07-09, under 510(k) number K241372.

Who is the listed applicant for Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™?

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

What is the FDA product code for Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™?

The FDA product code for Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ is MTD.

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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.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MedtronicK231312PENTARAY® 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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