K123605 is an FDA 510(k) clearance for the SMARTFLOW CATHETER. This device is classified as a Catheter, Ventricular (Class II - Special Controls, product code HCA).
Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on August 16, 2013, 268 days after receiving the submission on November 21, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4100.
| 510(k) Number | K123605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2012 |
| Decision Date | August 16, 2013 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCA - Catheter, Ventricular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4100 |