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FDA 510(k)

AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES

K-Number: K113628 · 2012-06-12

ApplicantCatheter Robotics, Inc.
Decision Date2012-06-12
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Robotics, Inc.. It received FDA 510(k) clearance on 2012-06-12 under 510(k) number K113628. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES?

AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2012-06-12. The listed applicant is Catheter Robotics, Inc.. The 510(k) number is K113628.

When did AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES receive FDA 510(k) clearance?

AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES received FDA 510(k) clearance on 2012-06-12, under 510(k) number K113628.

Who is the listed applicant for AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES?

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

What is the FDA product code for AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES?

The FDA product code for AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES is DXX.

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 Catheter Robotics, 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.

K122488AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES

Related Devices (Code: DXX)

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.

K262744GenesisX RMNStereotaxis, Inc.K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.K221464CorPath GRX SystemCorindus, Inc.K202275CorPath GRX SystemCorindus, Inc.K180517CorPath GRX SystemCorindus, 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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