The following data is part of a premarket notification filed by Millar, Inc. with the FDA for Mikro-cath Pressure Catheter.
| Device ID | K163376 |
| 510k Number | K163376 |
| Device Name: | Mikro-Cath Pressure Catheter |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | Millar, Inc. 6001-A Gulf Freeway Houston, TX 77023 |
| Contact | Jacqueline Jean-baptiste |
| Correspondent | Allison Komiyama Acknowledge Regulatory Strategies 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-01 |
| Decision Date | 2017-03-10 |
| Summary: | summary |