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FDA 510(k)

CRI STEERABLE CATHETER CONTROL SYSTEM

K-Number: K904787 · 1990-12-17

ApplicantCatheter Research C/O Burditt, Bowles & Radzius
Decision Date1990-12-17
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRI STEERABLE CATHETER CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. It received FDA 510(k) clearance on 1990-12-17 under 510(k) number K904787. 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 CRI STEERABLE CATHETER CONTROL SYSTEM?

CRI STEERABLE CATHETER CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. The 510(k) number is K904787.

When did CRI STEERABLE CATHETER CONTROL SYSTEM receive FDA 510(k) clearance?

CRI STEERABLE CATHETER CONTROL SYSTEM received FDA 510(k) clearance on 1990-12-17, under 510(k) number K904787.

Who is the listed applicant for CRI STEERABLE CATHETER CONTROL SYSTEM?

The FDA 510(k) record lists Catheter Research C/O Burditt, Bowles & Radzius as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRI STEERABLE CATHETER CONTROL SYSTEM?

The FDA product code for CRI STEERABLE CATHETER CONTROL SYSTEM is DXX.

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Other records listing Catheter Research C/O Burditt, Bowles & Radzius 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.

K924227CRI CYNOSAR CATHETERK924125CRI ELECTRONIC CONTROL SYSTEMK914523CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COILK904785CRI CYNOSAR CATHETERK900320CRI CYNOSAR CATHETERK884337MICRO-GUIDE SYSTEM

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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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