The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Cardia-cath.
| Device ID | K112323 |
| 510k Number | K112323 |
| Device Name: | CARDIA-CATH |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Contact | Fatma M Ali |
| Correspondent | Fatma M Ali MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2011-10-18 |
| Summary: | summary |