SMARTFLOW CATHETER— 510(k) K123605

Substantially Equivalent

Mri Interventions, Inc.

FDA 510(k) clearance K123605 for SMARTFLOW CATHETER, Substantially Equivalent on 2013-08-16. Applicant: Mri Interventions, Inc..

Clearance details

Applicant: Mri Interventions, Inc.
Product code: Code HCA
Advisory panel: Neurology
Date received: 2012-11-21
Decision date: 2013-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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