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FDA 510(k)

FIRMAP CATHETER

K-Number: K130827 · 2013-10-31

ApplicantTopera, Inc.
Decision Date2013-10-31
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 Topera, Inc.. It received FDA 510(k) clearance on 2013-10-31 under 510(k) number K130827. 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 2013-10-31. The listed applicant is Topera, Inc.. The 510(k) number is K130827.

When did FIRMAP CATHETER receive FDA 510(k) clearance?

FIRMAP CATHETER received FDA 510(k) clearance on 2013-10-31, under 510(k) number K130827.

Who is the listed applicant for FIRMAP CATHETER?

The FDA 510(k) record lists Topera, Inc. 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.

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 Topera, 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.

K133305RHYTHM VIEW WORKSTATIONK123295RHYTHM VIEWK110878RHYTHMVIEW (TM)

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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