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FDA 510(k)

FIRMap Catheter

K-Number: K153093 · 2016-04-07

ApplicantAbbott Electrophysiology
Decision Date2016-04-07
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FIRMap Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Electrophysiology. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K153093. 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 FIRMap Catheter?

FIRMap Catheter is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Abbott Electrophysiology. The 510(k) number is K153093.

When did FIRMap Catheter receive FDA 510(k) clearance?

FIRMap Catheter received FDA 510(k) clearance on 2016-04-07, under 510(k) number K153093.

Who is the listed applicant for FIRMap Catheter?

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

What is the FDA product code for FIRMap Catheter?

The FDA product code for FIRMap Catheter is MTD.

Other records listing Abbott Electrophysiology 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.

K171583RhythmView WorkstationK163709FIRMap CatheterK161240Rhythm View Workstation (non-streaming)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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