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FDA 510(k)

SMARTFLOW CATHETER

K-Number: K123605 · 2013-08-16

ApplicantMri Interventions, Inc.
Decision Date2013-08-16
Product CodeHCA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMARTFLOW CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2013-08-16 under 510(k) number K123605. The device is classified under product code HCA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTFLOW CATHETER?

SMARTFLOW CATHETER is a medical device that received FDA 510(k) clearance on 2013-08-16. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K123605.

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

SMARTFLOW CATHETER received FDA 510(k) clearance on 2013-08-16, under 510(k) number K123605.

Who is the listed applicant for SMARTFLOW CATHETER?

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

What is the FDA product code for SMARTFLOW CATHETER?

The FDA product code for SMARTFLOW CATHETER is HCA.

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Related Devices (Code: HCA)

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.

K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp.K031123CODMAN BACTISEAL BARIUM STRIPED CATHETERSCodman & Shurtleff, Inc.K021481BRESAGEN CATHETER, MODEL CS-3000Bresagen, Inc.K020728MIETHKE SHUNT SYSTEMAesculap, Inc.K013005ACT 11 MP VENTRICULAR CATHETERInnerspace, Inc.K003322CODMAN BACTISEAL CATHETERSCodman & Shurtleff, 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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