The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Orion Micro Catheter.
| Device ID | K113289 |
| 510k Number | K113289 |
| Device Name: | ORION MICRO CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Analia Nieto |
| Correspondent | Analia Nieto MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2012-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536027107 | K113289 | 000 |
| 00836462002579 | K113289 | 000 |