The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Smartflow Catheter.
| Device ID | K123605 |
| 510k Number | K123605 |
| Device Name: | SMARTFLOW CATHETER |
| Classification | Catheter, Ventricular |
| Applicant | MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Contact | Edward F Waddell |
| Correspondent | Edward F Waddell MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Product Code | HCA |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481006457 | K123605 | 000 |
| 04056481006440 | K123605 | 000 |
| 04056481006433 | K123605 | 000 |
| 04056481006426 | K123605 | 000 |
| 04056481006419 | K123605 | 000 |
| 04056481006402 | K123605 | 000 |