SMARTFLOW CATHETER— 510(k) K123605
Substantially EquivalentMri Interventions, Inc.
FDA 510(k) clearance K123605 for SMARTFLOW CATHETER, Substantially Equivalent on 2013-08-16. Applicant: Mri Interventions, Inc.. Device class: 2.
Clearance details
- Applicant
- Mri Interventions, Inc.
- Product code
- Code HCA
- Device class
- Class 2
- Regulation
- 21 CFR 882.4100
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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